Validation Manager Resume Samples

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A Fritsch

Archibald

Fritsch

2449 Sipes Pine

Dallas

+1 (555) 329 2440

2449 Sipes Pine

Dallas

Phone

p +1 (555) 329 2440

Experience Experience

Dallas, TX

Validation Manager

Dallas, TX

Kovacek and Sons

Dallas, TX

Validation Manager

Validation performance evaluation through Key Performance Indicators (KPI) and continuous improvement for highest efficiency of Regulatory Affairs operation
Train, develop, and provide leadership to the Validation Engineers to ensure protocols are written, executed, and reported efficiently
Perform risk assessments and develop / manage risk mitigation plans
Assisting in developing and maintaining a robust technical validation framework
Provide oversight and validation expertise during the development of new product and new technologies
Manage the training, development and succession planning for the direct reports. Other responsibilities as assigned
Assist in the implementation of common validation practices over the wider Catalent network

Los Angeles, CA

Software Validation Manager

Los Angeles, CA

Weimann and Sons

Los Angeles, CA

Software Validation Manager

Maintain staff by recruiting, selecting, and training employees. Maintain a safe, secure, and legal work environment
Manage team development through training, coaching and career mapping. Develop personal growth opportunities
Work with Site Quality, Software Quality, Manufacturing/ Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits
Collaborate with peers and stakeholders to identify opportunities for process improvement
Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
Provide validation training to engineers, manufacturing technicians or other staff on validation protocols and standard operating procedures
Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software

present

Philadelphia, PA

Computer System Validation Manager

Philadelphia, PA

Lindgren Inc

present

Philadelphia, PA

Computer System Validation Manager

present

Develop and maintain CS validation lifecycle maintenance including validation documentation, hierarchy, management of the revalidation/periodic assessments etc
Provide training on systems implementation and validation SOP’s
Provide compliance leadership, direction, and oversight in the area of Computer System Validation
Effectively manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
Support the on time project delivery by Coordinating and monitoring the validation/project phases and informing management of project progress
Assisting in audit preparation
Liaise and align with BMS Global teams for the implementation of enterprise systems and agree on testing strategies and service provisions

Education Education

Bachelor’s Degree in Engineering

University of Washington

Bachelor’s Degree in Engineering

Skills Skills

Demonstrated ability as an effective communicator with excellent presentation skills both written and verbal. Ability to influence at a senior level
Good knowledge of quality management systems
Excellent analytical and problem solving skills coupled with strong presentation skills. Excellent communication skills, both verbal and written
Excellent problem solving skills and the ability to quickly and effectively analyze critical issues and develop assessments for risk and impact
The role would suit highly driven self-starters, with a strong desire to challenge and deliver
Demonstrable evidence of interpreting & manipulating data clearly and accurately, with the ability to extract & clearly articulate key points
Ability to build effective working relationships (internally/ externally), establishing credibility amongst a wide and demanding client group (if applicable)
Ability to establish and follow robust, logical and auditable processes to complete a task or project
Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment
Strong interpersonal skills and problem solving ability

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15 Validation Manager resume templates

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Senior Software Validation Manager Resume Examples & Samples

Lead a team of senior and junior engineers in achieving software validation goals set by management team
Help Intel through innovation solution that increase test efficiency, save time and cost
Planning, organizing, and monitoring new initiatives, coaching junior engineers, manage multi-sites interaction, setting aggressive goals and defining how success is measured
Lead the effort of analysis, planning and execution of test against Intel's features related to data analytic, security, connectivity and manageability technology
Represent validation team in internal technical forum and PDT/PXT
Be the key proponent of modern software techniques and practices like Agile, Continuous Integration, Test Driven Methodology, and high automated testing

High Performance Compute System Validation Manager Resume Examples & Samples

Bachelor's degree in Engineering (Computer Systems Engineering or Electrical Engineering or Computer Science or equivalent) plus at least 10 years of relevant experience in engineering management
Demonstrated ability to manage a team of engineers on complex projects
Willingness to do detailed documentation
Self-motivated with the initiative to work independently as well as with a team
Ability to influence others through leadership and technical expertise
Ability to work successfully in a multi-site team environment
Good knowledge of computer architecture, system network architecture, platform architecture, and validation architecture
Knowledge of InfiniBand or other HPC interconnect is strongly desired

Functional Validation Manager Resume Examples & Samples

BS or MSc degree in Electrical or Computer Engineering or related field plus 8 or more years of relevant industry experience
Fluent English and Spanish communication
Minimum of 4 years' experience leading and/or managing teams with a proven track record of delivering business results for complex projects
Knowledgeable of digital devices functional validation methodologies and tools
Solid foundations on Computer architecture (Intel architecture knowledge is a plus)
Familiarity with lab test equipment: Logic and protocol analyzers, oscilloscopes
Effective problem solving skills and results-oriented mentality
A desire and ability to commit and deliver in a fast paced environment
Capable of working with cross-functional and cross-geo teams to achieve common goals
Capable of working with program managers to properly plan, fund and staff projects
Able to work in global technology companies and dealing with remote management and stakeholders

SVP, Senior Validation Manager Resume Examples & Samples

Lead validation staff focused on understanding and challenging the conceptual framework and assumptions of models, perform independent testing, identify model limitations, and identify model problems that need to be remediated
Conduct robust and comprehensive model validation testing and analysis according to PNC’s Model Validation Policy and Guidelines. Examine written model documentation, hold discussions with model developers, and collect data, assumptions, and code that are used in the models to perform the model validation. Occasionally validation teams will build benchmark models for comparison to the models they validate
Assess model risks and limitations and make recommendations on remediation of model deficits. Write detailed reports stating conclusions of the model validation and present findings and recommendations to senior leaders. Work with model owners to see that model deficits are remediated in a timely manner
Participate on various bank risk committees where models and their use, assumptions, and output are discussed
Contribute to the formulation and ongoing evolution of MRMG’s practices and procedures along with other MRMG managers and the Chief Model Risk Officer
Graduate Degree in Mathematics, Statistical Modeling, Computational Finance, Economics or related field. Ph.D. is preferred although a Master’s degree may suffice for candidates with sound experience
A minimum of 10 years model development and/or validation experience, with 15+ years experience being preferred. At least five years must have been in a supervisory role
Prior experience with a wide variety of models used by banks is required, but most essentially capital models (economic and regulatory), loan loss allowance models, and experience in evaluating models for stress testing (CCAR/DFAST) purposes
The ability to clearly explain MRMG’s validation work to regulatory staff and external auditors
Strong technical skills and problem solving ability. Proficiency in SAS and Excel required as the incumbent will be leading teams making heavy use of these tools
Demonstrated project management skills and the ability to work on multiple projects on a concurrent basis and be able to meet deadlines

Basel Validation Manager Resume Examples & Samples

Conducting walkthroughs, assessing the internal control environment by performing controls and substantive testing
Analyzing identified issues for their impact on capital and other upstream and downstream processes or systems, as well as escalating these issues
Cultivating relationships across the Finance organization with key constituency groups, such as Regulatory Reporting, Product Controllers, Operations, Treasury, Technology, Credit Risk, and Market Risk
Leads the professional development of staff
Ability to work within a team and to collaborate with peers and leadership to create effective solutions to validation issues
Sense of ownership and accountability for work
Proactive and recognized as a leadership role model, consulted often by others for advice and opinions
Minimum 5+ years of experience
Experienced with testing and proposing remediation plans

Validation Manager Resume Examples & Samples

Providing direction on Validation strategy and direction for the group
Overall responsibility for Validation master plan
Overall project Management of Validation projects
The review and approval key validation related documents
Validation performance evaluation through Key Performance Indicators (KPI) and continuous improvement for highest efficiency of Regulatory Affairs operation
Integrate, contribute, and/or lead cross-functional project teams as required
Collaborate with internal and external partners, vendors, contractors, as required
Lead and manage the validation group
Demonstrated knowledge of current regulatory requirements pertaining to validation within a medical device environment
The ability to continually adapt to a changing regulated environment and provide direction and guidance to best practices in validation management and execution
Good financial acumen and understanding of the requirements to manage the group within the financial constraints of a business
Demonstrated ability to lead teams to complete activities in effective and efficient manner
Possess highly developed interpersonal skills
Be competent in meeting customer's requirements whilst managing their overall expectations
Strong report writing and presentation skills are essential
A working knowledge of Statistical techniques and analysis
Extensive experience in defending Validation during regulatory inspections
Current knowledge, experience and/or proven interest in efficient and integrated approaches to Validation / Change Control
Lean and Six Sigma training would be advantage

Senior Validation Manager Resume Examples & Samples

Knowledge of cGMP's and other worldwide regulatory requirements
Problem solving ability and excellent oral and written communications skills
A third level qualification in Science, Engineering or a relevant Quality discipline
Minimum 8-10 years experience in a similar role

Senior Software Validation Manager Resume Examples & Samples

Evaluate test frameworks for unit, UX and cloud based testing technologies and implement as appropriate
Manage quality using BI and Crashlytics metrics and implement test strategies to reduce crashes and improve overall stability
Create test plans and test cases based on software requirements and hands-on product experience with mobile applications
Execute test cases
Report, reproduce, and verify fixes for bugs
Significant hands-on testing and test plan creation experience
Significant experience with bug tracking software and bug reporting protocols
Mobile platform testing including iOS and Android-based phones and tablets
Knowledge of software testing fundamentals and principles

Validation Manager Resume Examples & Samples

Managing the Validation Maintenance program, inclusive of validation plans, schedules and driving operational improvements into the manufacturing site
Maintaining systems to monitor and track team metrics
Representing the validation team on cross-site and enterprise projects
Providing oversight of the validation labs and equipment to maintain the validation program
Representing the validation function to Commercial CMC teams
Providing technical support for product / process transfers into and out of the biologics manufacturing site
Providing validation assessments to determine scope of validation needed for automation, equipment, facility, utility changes for Shire’s internal manufacturing operations
Supporting inspection and inspection readiness activities
20%
Bachelor's or Master's degree in Biology, Chemistry, Chemical Engineering or related field with a minimum of 8-10 years relevant experience in the biotechnology and/or pharmaceutical industry. An advanced degree or additional industry certification is a plus
Experience in successful management of complex validation projects is required
Validation oversight experience in a biologics manufacturing facility
Proven people manager and leader capable of developing people and teams
Operational Excellence experience to ensure value added and effective operations
Advanced degree in complimentary field of study is a plus

Bluetooth SW Validation Manager Resume Examples & Samples

15y+ of experience in SW development and/or SW validation
7y+ of management experience
Master's in Computer Science, Electrical Engineering or related field
Wireless knowledge in general and BT/BLE/ZigBee in particular it is an advantage

IPB Control & Validation Manager Resume Examples & Samples

Degree in accounting, finance, business or a related field; MBA preferred
Experience in audit / examinations environment is a must
5+ years of previous banking experience (AML and Operational Risk Management experience is a plus)
Specific experience working in compliance internal controls or audit role for financial institutions preferred
Experience in the retail banking industry
Good planning and project management skills
Proficient in the use of Microsoft applications (Word, Excel and PowerPoint)
Successful candidates must work in excess of standard hours when necessary. Second language skills (Spanish) and international business experience are preferred

Validation Manager Resume Examples & Samples

Establish simple, efficient, and compliant Validation Procedures and templates
Establish and maintain the GFO Master Validation Plan
Develop validation best practice templates and training program and perform the training to all applicable GFO employees
Create and maintain compliant Statistical Technique. Test Method Validation, and Software Validaiton procedures that align with the corporate policies
Review and approve all GFO protocols and reports
Perform and manage validation projects as assigned
Review and understand validation projects to assure comprehensive development plans to prepare for effective implementation
Monitor and evaluate project and validation program progress and results
Maintain and enhance cross-functional team relationships. Work with divisional customers, internal functions, and suppliers to accomplish quality and business objectives, and to maintain and improve the quality of communication
Provide guidance and approval regarding quality strategies and approaches
Work with other Quality Management, develop budgets, and monitor spending
Understand and effectively participate in design control activities as applicable
Interface with regulatory agencies as required (FDA, ISO, PMDA, International)
Excellent verbal and written communication skills with all levels of management and other technical organizations
Knowledge of and experience with FDA, ISO, and international auditing
Knowledge of risk management, design control, process validation, inspection, and auditing principles
ASQ Quality Engineer, Quality Manager, and/or Six Sigma Black Belt certification desirable
Experience with statistics, sampling plans, and statistical software (Minitab)
Customer/quality focused
Business results-aligned
Technically competent
Ethical behavior
Idea generator
Facilitator
Leader
Motivator
Sees the big picture
Effective listener
Perseveres despite obstacles

Software Validation Manager Resume Examples & Samples

Provide leadership and direction to the consumables Process Engineering team to accomplish all team goals and objectives
Maintain staff by recruiting, selecting, and training employees. Maintain a safe, secure, and legal work environment
Manage team development through training, coaching and career mapping. Develop personal growth opportunities
Work with Site Quality, Software Quality, Manufacturing/ Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA and other country-specific agency audits
Assess new and existing systems and processes against cGMP and ISO 13485 requirements for process validation and determine when re-validation is required
Ensure site/system validation program meets requirements of FDA (21 CFR Part 11 and 820), ISO (13485 and 14971)
Maintain validated state under Site Validation Master Plan and update Site Validation Master Plan as needed
Collaborate with peers and stakeholders to identify opportunities for process improvement
Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
Provide validation training to engineers, manufacturing technicians or other staff on validation protocols and standard operating procedures
Coordinate and participate in development, testing, and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software
Assist with development and review of system/software requirements to ensure testability
Perform functional and process risk assessments in conjunction with Quality and Engineering subject matter experts
Perform equipment IQ/OQ/PQ, gauge R&R (repeatability and reproducibility), test method validation, and spreadsheet validation
Author software/system validation plans, protocols, and reports for consumables manufacturing and release
Facilitate execution of validation protocols and review objective evidence for inclusion in validation reports
Assist with documentation and resolution of deviances and variances that occur during validation
Assist with determination of root cause, impact, and resolution of problems impacting production
Partner cross-functionally with R & D, Quality, Manufacturing and other engineering groups to develop processes for new products and sustain and improve processes for existing products
B.S./M.S./PhD in an engineering or science field with at least 7 years of relevant experience and at least 2 years as a technical manager in a cGMP environment

Validation Manager Resume Examples & Samples

Oversee the change process of the Digital Health Platform (cloud) ensuring compliance with regulatory requirements
Proficiency understanding Software development and implementation (including cloud implementation)
Help update project plan, and follow up project progress, so milestones are met on time and properly
Maintain the validation program, ensuring correct implementation of validation plans in compliance with corporate and regulatory requirements
Support test management activities, creation and approval of test plans
Be a liaison between Patient Technologies and software vendors, Teva compliance and privacy personnel, and external regulatory consultants
Creation of SOP documentation for software implemented by Patient Technologies. Including operation and maintenance of software
Creation and maintenance of SOP for Quality Management System that support Patient Technologies needs, while maintaining the regulated requirement
Colaborate with Product Manager to define clear requirements, and milestones for development projects
Participate in scrum meetings for software development
Ensure the Requirement Traceability matrix is maintained, and defect management is documented and completed
Write and maintain Standard Operation Procedures (SOP) for the Patient Technologies department, as requested by the Medical Software Validation/Project Manager. Ensuring procedures help to manage the project deliverables and updates are in compliance
Other project documentation and duties as required
Manage change of implemented systems in a control manner
Proficiency understanding software development
7+ years’ experience in Software Validation and Medical Devices
Experience working with standards like IEC62304/ISO 13485/ISO 14971
5+ years’ experience working in Medical software as QA Engineer
Proficient in HP Quality Center and Jira
Working experience on 21CFR Part 820 and 21 CFR Part 11
Solid IT Operations Experience
Medical Device IT experience: 7 + years
Cloud software Development/Validation/Operation
Possess exceptional documentation skills for creating, and editing documented deliverables
Detail oriented, and thrives in a fast-paced, dynamic environment
Solid understanding of modern IT concepts, and systems

Validation Manager Resume Examples & Samples

Ensures full ownership of validation plan (including subsystems and components) and optimizes its efficiency regarding risk coverage
Minimises gap with platform generic validation plan
Gets product certification in due time
Manages de validation and certification tests
Complies with WP execution QCD commitments
Leads and supervises the global validation process, integrating components and subsystems contributions and ensuring REX is fully taken into account

Dimensional Validation Manager Resume Examples & Samples

8+ years of combined experience in project management of tooling and gages, facility and equipment, or dimensional control
Basic metrology knowledge
Good coordination and communication skills
Good computer skills and effective reporting skills
Advanced degree preferred in the area of engineering or management
General knowledge of procurement
CAD knowledge

Validation Manager Resume Examples & Samples

Review and prioritise all required validation activities based on their business benefits in terms of quality, compliance, service and cost. Allocate resource accordingly and ensure timely execution of the validation activities
Develop, implement and maintain an effective communication tool to reflect the validation workload requirement, prioritisation process and communicate to other function the validation projects execution plan
Maintain project activity/timeline/progress charts. Report routinely to project leader/ stakeholders
People management: Validation Scientists & Validation Contractors
Provide clear visibility to the Operation on the validated status of product / equipment required for Zydis manufacture
Perform Validation impact assessments for any significant changes proposed to the Zydis process / product and equipment, for any significant process deviation
Ensure the system used to perform Validation reviews is adequate to maintain equipment and process in validated status
Establish the Validation Master Plan for Process and Equipment and review quarterly
Continuously review the validation approaches against cooperate policies, regulatory requirements and best practice, to achieve and maintain excellence in ways of working
Participate in the periodic review during product life cycle (APRs, reviews etc.) to deepen process performance understanding, highlight trends and suggest improvements to increase process capability
Assist in the implementation of common validation practices over the wider Catalent network
Provide oversight and validation expertise during the development of new product and new technologies
Ensure all validation programs are designed to achieve right first time regulatory approval
Participate in customer regulatory filling reviews
Manage the training, development and succession planning for the direct reports. Other responsibilities as assigned
BSc/MSc or equivalent in relevant discipline
Broad and deep understanding of Pharmaceutical Validation Requirements and Regulatory Expectations
Experience in developing and implementing validation systems
Experience in Change control
Experience in managing a technical team
Communications skills – verbal / written (to engineering, operations, quality, customers, auditors)
Able to assess business benefit and prioritise workload accordingly
Influencing skills – to work across functions and with customers to represent and justify Catalent position for validation approaches
Strong consultative, but results-oriented approach to problem solving
Ability to work under pressure and tight deadline
Creative thinking to identify compliant but innovative validation strategies
Ability to learn and retain technical information
Well organised with ability to handle multiple activities simultaneously

Senior Validation Manager Resume Examples & Samples

Identify core competencies, resources and trainings required to establish the organizational capability for Process Validation at the site
Lead Alere team on day to day support and direction of process validation work across all platforms and disciplines
In conjunction with QA site leadership Sponsor and support integration of Process validation into design control
Establish a re-validation periodic review program and participate in a validation review board at the site level
Connect, Coordinate and Communicate with the broader Alere organization to incorporate best practices
Manage within an organization that is not deeply trained in the best practices of Validation
Expert knowledge of management skills includes the ability to navigate the organization while gathering domain knowledge from internal clients and sharing validation concepts and principles in two way collaboration
Mentor, coach and train validation team and associates to establish validation competencies
Plan, coordinate and direct the tasks of department staff (validation team) including product leads to complete major functional objectives
Participate in Lean Initiatives and activities
Demonstrate high commitment to quality compliance while balancing, practical organization business risk
Perform tasks to accomplish goals with minimal organization disruption while fostering positive working relationships
Define a comprehensive validation plan that addresses both chemical and mechanical systems that are integrated into the risk management program/documentation
Demonstrate strong understanding of 21 CFR 820, GHTF and ISO guidelines, in addition to the USP that governs the chemical testing. These tasks need to be applied to approval and compliant documentation practices
Collaborate with manager to establish objectives, milestones, and timelines for completion. Report progress and results to manager on a regular basis
Establish and maintain lines of communication to ensure the timely and accurate flow of information

Project Validation Manager Resume Examples & Samples

Build the validation management plan and test list and updates as necessary
List and include the critical points
Define the strategy for validation on the Product development and project execution
Define the Planning for all Validation activity
Write validation specification for Combined Test, Operational Test
Validate the programs and the test specifications
Follow the Design Review execution
Execute of the validation activity, including verification (calculation, mock-up), Sw testing, combined tests bench, static test and dynamic tests
Follow-up of the validation activity, including approval and documentary (archive) management
Ensure full ownership of validation plan (including subsystems and components) and optimizes the efficiency regarding risk coverage
Minimizes gap with platform generic validation plan
Get product certification in due time
Manages the validation and certification tests
Lead and supervise the validation process, integrating components and subsystems contributions and ensure REX is fully taken into account

Verification & Validation Manager Resume Examples & Samples

Participate in technical reviews and contributing to tech discussions
Contribute in decision making for make/stop a release
Analyze requirements and report out testable/not testable
Report out defects in products & design
Leverages knowledge in advanced aspects of technical/functional areas and applies technical theory and practical experience with input from relevant functional areas to solve complex problems
Works independently and possesses a level of functional expertise necessary to influence and execute technical and project delivery execution
Works with customers and/or program leadership to ensure that the project deliverables are consistent with the goals of larger programs or initiatives
Supports mentoring of junior technical talent
Accountable for implementing and teaching engineering standards
Bachelors degree in Engineering or related field; or equivalent (defined as a High School Diploma/GED and 4 years relative work experience)
4 years relative work experience
Good knowledge of product application usage
Should have very good knowledge of testing methodology/processes and product development life cycle
Strong in manual/automated testing methodologies
Work well with teams and across global environment
Experience managing verification projects and staff
Self-starter, energizing, results oriented, and able to multi-task
Demonstrated problem solving ability and results orientation

Validation Manager Resume Examples & Samples

Oversee validation group and projects; assign workload; review documents; schedule regular meetings with QA to identify and ensure compliance of instrument qualification and software validatons projects
Develop training program for group members and facility
Develop/modify templates for system life cycle suite of documents including evaluation checklist (pre purchase)
Develop additional validation/qualification/system SOPs as required
Review of all system SOPs to ensure compliance requirements are met and qualified/validated state is mainteianed
Maintain VMP, Vendor questionnaires as applicable
Collaborate with other Wuxi sites to share validation efforts
Other projects related to compliance of systems
;Responsible for planning, scheduling, execution and leading validation project assignments in coordination with the IT Manager and in accordance with Good Laboratory Practices (GLPs) and FDA 21 CFR Part 11
Validation assignments include validation, qualification, and implementation of new and existing, processes, equipment, software, and instrumentation systems
Leads cross-functional project teams in the development and implementation of the validation plan and protocols
Prioritizes, manages and executes multiple projects utilizing Project Management methodology. This may include assignment/oversight/review of validation projects to other personnel/teams
Review and approve all validation documentation (plans, protocols, summary reports, etc), including vendor documentation
Acts as the primary Validation contact source for vendors, the FDA, and sponsors. Provides support for regulatory submissions and regulatory agency inspections as required
Maintains a thorough knowledge of the organization, policies and Standard Operating Procedures (SOPs), adheres to all organizational standards defined in SOPs and the WuXi Employee Handbook, and coordinates with IT team activities
Support development of best demonstrated validation practices within the IT department, based on current industry practices and guidelines
Champions continuous improvement of WuXi’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout WuXi
Bachelor’s degree applicable to a pharmaceutical R&D environment
Minimum of 5-10 years experience in a regulated, GxP environment validating and qualifying laboratory equipment, computer systems, and processes
Extensive, in-depth knowledge and understanding of Good Laboratory Practices (GLP) and quality requirements in an FDA-regulated environment along with knowledge of 21 CFR Part 11
Exceptional written and verbal communication skills with superior organizational skills
Excellent problem solving skills and the ability to quickly and effectively analyze critical issues and develop assessments for risk and impact
Ability to utilize Project Management methodologies to manage validation projects
Ability to work in a high pressure, fast-paced, environment
Ability to work with various scientists and management across various departmental groups to achieve company’s goals and objectives
Ability to work independently and manage time with respect to project priorities
Have thorough understanding of the Bioanalytical Process
Ability to operate instrumentation within the limits required for validation development and execution, with the appropriate training provided by XBL staff or the vendor if required
Advanced knowledge and experience of complete MS Office system
Firm understanding of all associated technology platforms as needed for validation projects
Ability to effectively manage other Laboratory Informatics Systems as assigned

IT Quality Validation Manager Resume Examples & Samples

Designs the organizational structure and work processes to ensure an effective and efficient delivery of IT quality control services including computer systems validation activities
Manages the validation program for existing and new computer systems. Ensures compliance with applicable regulatory requirements
Provides overall direction and expertise for administration of validation/revalidation policies, Standard Operating Procedures (SOPs), and Work Instructions
Provides direction and participates in validation protocol development, review, and approval
Evaluates proposed changes to computer systems to determine validation or re-validation requirements and defines qualification strategy
Implements industry standards and functions as the authority on validation strategy, procedures and techniques, and regulatory compliance
Participates with other functional group members in the review and approval of requests to change existing validated systems and proposals for new Good Practice (GxP) systems
Approves and authorizes system changes based on review of information and impact on current validated state of regulated computer systems
Reviews and/or recommends actions with respect to the investigation of deviations and the disposition of nonconforming systems
Line management responsibilities including professional development, performance appraisals, and employee counseling for Quality Control staff. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level and according to business priorities

Software Verification & Validation Manager Resume Examples & Samples

Possess a strong commitment to company values
Own the high level verification strategy for application software(s) for medical devices
Hire, promote, and grow software verification team. Mentor team members in best practices and skills development. Identify, and encourage team members to seek, opportunities for professional growth and provide guidance and support as required. Provide periodic reviews of team member performance using both formal and informal methods
Work with cross functional teams to discover and implement improved processes for software development life cycle
Oversee development of test plans, verification strategies and traceability and provide direction to test engineers in their implementation
Works collaboratively with software development and other test managers in multiple sites to create resourcing and execution plans including any hand-offs, regularly tracks team progress against objectives, identify and manage organizational risks to ensure successful accomplishment of objectives
Provides status reports, metrics and updates for current projects to management
Provide input to company strategic planning and budgeting exercises
Work with Program Management to provide estimates and project schedule inputs
Participate or collaborate with cross functional teams in evaluation of tools, test development, automation environment used for software verification
Work with the Regulatory and Quality departments to ensure software verification strategy, test plans/report meets or exceed all applicable regulatory and quality standards
Support regulatory submissions of software verification artifacts
Work closely with the QA department to maintain and improve quality assurance in compliance with FDA regulations and other regulatory agencies
Act as an effective hands-on member of a cross-functional team which is directly involved in the application development life cycle of medical device software

Validation Manager Resume Examples & Samples

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Coordinate and lead CIPT / supplier resources to meet engine test milestones and hardware delivery requirements
Plan & manage task budget and schedule in accordance with program negotiated deliverables
Prepare and present task status and technical content to the CIPT and Cold Section Engineering management
Perform risk assessments and develop / manage risk mitigation plans
Lead and execute War On Cost and Fleet Sustainment initiatives
Review and process all required development engine engineering changes (DECX)
Coordinate evaluation and disposition of quality non-conformances (QNs) and supplier requests for information (SRI’s)

System Validation Manager Resume Examples & Samples

Strong experience with automation, networking processors, test database, product QA, data analytics
Knowledge of WI-FI protocols preferred. Ability to troubleshoot as needed to solve problems. Problem reporting should include a full analysis of test scenario used and the issue found
The candidate should be very familiar with the use of test tools and be able to analyze traces and isolate problems from the information gathered in the traces
Enterprise wireless networks require a very strong understanding of L2 & L3 networking
The candidate must possess good knowledge of wired and/or wireless networking in general
Understanding of application processor technology is a plus
Experience in scripting using TCL, Expect, Python & Perl will be considered
Strong written and verbal communications including the ability to document test plans, test results and to interpret test results into actionable recommendations

Silicon Validation Manager Resume Examples & Samples

Experience with some of these activities or technical areas
Validation plan development, test plan execution
Debug and triage of deemed-SoC failures
Chip design-for-debug (DfD), design-for-test (DfT) feature architecture and debug tool development
Web development, DevOps/SRE, system administration, Big Data
SoC IP test development
Product and test engineering
Logic design and verification, hardware prototyping (FPGA, emulation), board design and bring-up
SoC, CPU and GPU architecture
Embedded software, firmware, system and kernel programming
People and project management skills
In addition
3+ years of experience managing a team of 10+ engineers
10+ years of relevant industry experience as an individual technical contributor

Engineering & Validation Manager Resume Examples & Samples

Providing coaching and support to the Technical and Engineering colleagues, including the identification and development of key talent and skills within the team
Drive the team’s performance so that every individual understands their individual contribution and how it impacts the site
Responsible for Technical and Engineering planning and decisions for the Vaccines IPT, to ensure supply of high quality product through tactical planning and execution of production schedules
Consistently deliver on key performance metrics, e.g. EHS metrics, Compliance, HPO and budget performance
Responsible for strategic planning for the IPT, in liaison with Technology CoE
Sound financial stewardship, management and control
Responsible for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the process
Proven track record of delivering high performance through development and coaching of a team
Process and technology background: the successful candidate will fully understand how to drive optimisation
Demonstrated ability in holding team members accountable for results and managing performance
Demonstrated ability to fully realize improvement initiatives
Demonstrated successes in a team environment, such as project teams, Six Sigma team, Tier 4’s etc
Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
Ensure the highest Quality, Compliance and Safety standards
Participate and comply with the MSD MANUFACTURING DIVISION Quality Management System (QMS) requirements, including ownership, as relevant
Masters in a Science or Engineering discipline (preferably Biotechnology)
Green Belt or suitable alternative in MPS
Evidence of Continuous Professional Development
> 5 years’ experience in Pharmaceutical / Biopharmaceutical industry or a similar operating environment
> 5 years’ experience in a leadership role in a manufacturing environment
Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.)
Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment
Demonstrated experience with Industrial Relations
Demonstrated leadership, including change management skills with a continuous improvement focus

Ccar / Basel Validation Manager Resume Examples & Samples

Overseeing key components of the Validation Framework. Reviews include the following products: derivatives, loans, securitizations, and other debt and equity. Report coverage includes the FFIEC 101 (Basel III Advanced Approach); FR Y-9C, FFIEC 041 (Basel III Standardized Approach), DFAST, CCAR
Overseeing the Validation Test Plan and providing various governance committees with progress metrics
Monitoring, tracking and reporting project progress to Senior Management
Prior experience in a line role or supporting a finance or reporting function
LI-TM1

Senior Validation Manager Resume Examples & Samples

Qualified actuary with a strong quantitative academic background (Master or PhD in Mathematics, Statistics, and Econometrics)
At least 5 years of experience, including a strong exposure to Solvency II (development, execution and/or validation of internal model)
An excellent level of communication and assertiveness
Fluency in English and French or Dutch
Good knowledge of actuarial software and Office suite would be an asset

Computer System Validation Manager Resume Examples & Samples

CSV SME with responsibly for the validation of, at a minimum, Automation systems consisting of Batch Execution Systems, Enterprise Systems, Laboratory Equipment, Data Historian (OSI Pi) and a Reporting system in conjunction with the site CSV CQV team
Maintain validation philosophies and master plans required to drive the computer systems validation lifecycle for a fully automated biologics site
Develop and maintain CS validation lifecycle maintenance including validation documentation, hierarchy, management of the revalidation/periodic assessments etc
Ensure alignment with BMS directives and industry guidelines on Computer system validation
Effectively manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
Deliver regulatory inspection readiness training, coaching and guidance to junior level staff to become subject matter experts (SME) and ensure CS validation philosophies are well understood and represented to regulators
Liaise and align with BMS Global teams for the implementation of enterprise systems and agree on testing strategies and service provisions
Meet on a regular basis with global CSV team to align on requirements and testing strategies
Support the on time project delivery by Coordinating and monitoring the validation/project phases and informing management of project progress
Assisting in audit preparation
Presentation of the above systems for internal, vendor and regulatory audits (e.g. HPRA and FDA)
Be the main point of contact in providing regulatory guidance and support in the management of system upgrades, changes and general validation challenges, and providing support in identifying the need for creation/updating operating procedures or templates
Providing value added support and constructive comment on CSV operational procedures, representing the area at designated meetings, performing peer review of documentation and additional duties as required by management
Point CSV person for review for all associated vendor packages and corporate systems
The candidate will hold a minimum of a BSc qualification (Degree) in a scientific, technical or engineering discipline along with 10+ years of experience working with Computer Systems for pharmaceutical manufacturing facilities. A Strong background in validation and biologics manufacturing is desired
Knowledge of regulatory validation requirements including FDA (21CFR, part 11), EMA (Annex 11), GAMP and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9)
Experience dealing with regulatory agencies

Software Validation Manager Resume Examples & Samples

Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team
Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities
Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals
Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program
Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives
Interface with customers on technical/quality issues and improvement initiatives
Responsible for managing customer audits and regulatory/compliance agency audits
Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures
Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry
Provide technical support during Flextronics FDA inspections in Europe, Asia and America
Work with Site Quality, Software Quality, Manufacturing/ Operational Excellence, Regulatory, and Engineering subject matter experts to prepare for and support FDA audits and other country-specific agency audits
Assess new and existing systems and processes against 21CFR11, 21CFR820 and ISO 13485 requirements for developing device software as well as process validation and determine when re-validation is required
Provide regulatory compliance guidance and direction in order to meet with GMPs, FDA 21CFR820, FDA 21CFR11, GAMP and applicable regulations for computerized systems
Maintain validated state under Corporate Software Validation Master Plan document as needed
Facilitate communication and implementation of standard processes across global manufacturing sites
Perform and/or support Software Validation activities, Software Verification activities to GxP systems including spreadsheets
Actively work with development teams on digital health software (medical software applications, cloud based software, patient privacy, etc) for medical products, including the infrastructure and verification / validation methods

Validation Manager Resume Examples & Samples

Lead, direct and manage the validation (calibration, commissioning and qualification) of facilities and equipment in CACT, Maloney and Ravdin such that it remains in a state of compliance with internal and relevant regulatory standards
Using a risk based approach based on ISPE guidelines, directs and oversees calibration program and ensure calibrations meet or exceed relevant industry standards for FACT accreditation and cGMP compliance
Lead and manage validation contractors on large scale projects to ensure the calibration, commissioning and qualification goals of quality, schedule and cost are met. Assures overall Validation Master Plan program requirements are met
Create, execute and review IOQ protocols for new and existing equipment. Ensures facilities and equipment are qualified in a timely manner to meet the needs of manufacturing
Maintain ISO certification status of clean rooms for CACT, Maloney and Ravdin by ensuring HEPA filter certifications, BSC certifications and air balancing of clean rooms are compliance with ISO standards
The minimum of a BS degree from accredited university and 5 to 7 years of relevant industry experience in a cGMP or FACT accredited environment or an equivalent combination of education and experience
Project Management experience and proficiency with MS Project
Proven ability to plan work up to 12 months in advance
Familiarity with ISPE guidelines for Commissioning and Qualifications
Experience managing external contractors for calibration and validation activities
Experience in Biotechnology Industry
Experience with ISO Class 7 and 8 clean rooms
Experience with Validation Master Planning
Experience developing calibration and qualification programs

Validation Manager Resume Examples & Samples

Mange the Capital Validation team, ensuring oversight and delivery of all projects to the Worthing site
Interface with the project teams, and key third party expertise (vendors and sub contractors) to execute the overall Qualification phase project plan and schedule which include FATSAT/commissioning, installation and operational qualification for all systems
Ensuring Qualification program alignment with GSK site and corporate validation standards. All design standards are in line with engineering best practices
Provide QA oversight to ensure Qualification program is followed as per site procedures and the GSK QMS
Develop the performance qualification master plan, identify task lists and project timelines in line with the objectives and goals of the project
Manage and close major deficiencies (punch list and exceptions list) in time before next phase, and eliminate road blocks
Handover the project in a fully operational and compliant state to the value stream and QA for Validation maintenance

Commissioning / Validation Manager Resume Examples & Samples

Project Management on both technical issues, and financials
Interaction with client engineering, validation, quality departments during project management and execution of projects
Assisting with business development to bring in future work with current and new clients
Learning safety policies,and ensure compliance with staff
BA or BS in Engineering or Scientific related field
10+ years commissioning experience
Prior Project Management experience
Ability to travel within U.S., Puerto Rico and Canada

Validation Manager Resume Examples & Samples

Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
Post-graduate studies as appropriate to augment primary degree
10 years’ experience working in a Healthcare-manufacturing environment – ideally part of which would be in the pharmaceutical sector
5 years’ experience in validation environment in a leadership role
Team Leadership skills
Able to lead projects to plan
Good communication skills at organisation, team and individual levels
Understands & champions KPI’s for the site
Capable of troubleshooting validation issues associated with projects, process development
Competent technical knowledge of pharmaceutical plants
Knowledge of requirements for of GAMP, ISPE Baseline guides
Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines
Full understanding of relevant quality and compliance regulations
Good knowledge of quality management systems

Validation Manager Post Si Validation Resume Examples & Samples

Lead a team of 8-10 people including technical direction/ramp, training, guide their career development, performance evaluation, and motivation
Responsible and accountable for teams deliverables and results with quality
Work with IP designers, Concept Engineers, verification and validation teams across sites to collect requirement on validation capabilities required
Closely work with project and program managers to align BLR activities with overall program of microcontroller development
Create project schedules, from bottoms up, for validation capabilities and drive alignment to overall program schedule
Collect requirement from team members, to perform their duties, e.g. trainings, Silicons, HW/SW tools, Debuggers, boards, etc., and work with local and cross-site management to provide solutions
Work with management on strategic objectives and drive initiatives
Ramp on Silicon validation using functional and requirement based validation methodologies to effectively design and deliver the quality product
Build a collaborative environment across different Geos (Munich, Bristol, Singapore, etc) and maximize contributions to the organization
Meet or exceed customer expectations
Become central point of contact in Bangalore and expand to influence across MC D organization with positive impact
Lead validation capabilities team to energize and motivate
Demonstrate results with improvements and deploy processes across MC D organization
Drive initiatives to achieve quality, meet or beat schedule and efficiency
Escalate issues, with appropriate data, to management to see immediate actions

CCB Remediation & Correction Code Validation Manager Resume Examples & Samples

Develop, execute, and continuously improve the strategic approach of the Code Validation function
Develop, maintain, and continually improve process and procedures within the Code Validation function
Day to day management activities and resources within the Code Validation function
Coaching and development of resources within the Code Validation function
Accountable for adherence to policy, procedure, and controls
Interface with various levels of management to report progress against plans and goals
Provide insight on the level of effort, test environment requirements, identify resource/skills and validation schedule to management
Manage communication and interface between the testing team and the Central Remediation and Correction team as well as other Correction functions (i.e. On-boarding, Project Management, Execution, and Quality management)
Experience in a leadership role supporting quality management / testing within a matrix
Ability to manage multiple initiatives simultaneously
Demonstrated skills in quality assurance methods/processes and practices
Ability to work well in a matrix type organization and work collaboratively
Project coordination and project tracking experience and skills
Strong background in metrics based monitoring and reporting
Strong leadership and interpersonal skills, ability to influence others for results
Demonstrable experience with Testing tools such as ALM
Experience or knowledge SQL, UNIX, MS Office tools
Direct working experience and/or expertise with Chase Data environments (i.e. ICDW)
Experience with Tera Data and or Oracle database environments (Tera Data preferred) and SAS preferred
Possess a sense of urgency, excellent analytical and problem solving skills, and ability to adapt to a rapidly changing business environment

IT Quality & Validation Manager Resume Examples & Samples

Drive continuous improvement of the QMS quality system to meet and sustain compliance with internal and external regulatory requirements
Conduct quality & validation reviews to evaluate processes and deliverables to fulfil the requirements for quality to un-cover errors or deficiencies and to identify strengths and opportunities for improvement
Follow up resolution of identified quality & validation exposure and escalation of critical situations are not resolved in due course
Contribute to business decisions in the definition and assessment of IT quality & validation requirements
Drive and facilitate the creation of relevant QMS related SOPs
Interface with business and IT partners to ensure RDC IT quality & validation practices are aligned with regulatory expectations and industry best practices
Liaises with business quality in regard to IT quality & validation process governance and RDC IT Quality Solutions
Manage the document workflows of HPSM, DocIT2 and GRC Tool
Perform CSV and PMM Trainings to RDC internal and external personnel
Minimum Travel required 20%

Method Validation Manager Resume Examples & Samples

Oversee late stage development, qualification and validation of inspections methods for consumable products
Interface with Engineering, R&D, Quality and Regulatory departments to ensure project activities are on time and meet performance goals,
Interface with Senior Management regularly on program status
Mentoring, coaching, and facilitating reports in order to set them up for success and provide for career growth both technically and managerially,
Coach and facilitate functional group members in carrying out their responsibilities on various project teams and,
Provide expert technical input with respect to method validation requirements and related Regulatory requirements
Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO
10+ years of experience in analytical method development, qualification, validation and transfer
5 years functional or program management experience, preferably in Method Development/Transfer or Quality Control
Experience with product development process and project management skills are required
Must be an effector communicator, able to effectively lead teams and interface well with the organization
3- 5 years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/development reports; validation master plans
Expert user level experience with many of following techniques: HPLC, LCMS, GCMS, Maldi-TOF, ICP-MS, UV/fluorescence spectroscopy, NMR, biochemical (enzyme) assays
Expert knowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH / USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls

Validation Manager Resume Examples & Samples

Planning and managing validation of high cost, complex, strategic systems using risk based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes
Ensuring completion of Periodic Compliance Review activities and negotiating the required corrective actions
Validation planning for projects including project interaction with IT, software suppliers, and outsource companies
Project problem resolution/avoidance – this typically involves ongoing interaction with IT Managers/Directors, site Validation Managers and senior management of suppliers
Managing the deployment, maintenance and inspection support of multiple (3-7) global projects including responsibility for the developing solutions that maintain compliance and keep validation on schedule and on budget
Managing the collection of data for the assigned KPIs and Service Level Agreements
Managing Contingent Workers assigned to project activities including budgeting and forecasting of project costs
Providing Compliance oversight and training to internal and external suppliers, e.g., IT teams outside GMS and globally sourced providers, as applicable
Minimise project costs with efficient planning and timely resolution of issues whilst ensuring compliance
Proven ability to manage the validation, deployment, change management, and inspection support of large, complex, computerised systems (with no significant inspection/audit issues), including development/provision of training and consulting to customers
Proven ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality
Proven ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation
Proven ability to manage staff assigned to multiple validation projects and experience in coaching/mentoring various personnel in validation principles and activities
Expert technical knowledge of analytical and manufacturing technologies, engineering practices, validation and GMP compliance for computerized systems used in the manufacture and distribution of pharmaceutical product
Proven ability to summarise key ideas from complex issues and communicate them simply, clearly, and concisely to deliver compelling messages
Demonstrated ability as an effective communicator with excellent presentation skills both written and verbal. Ability to influence at a senior level

Computer System Validation Manager Resume Examples & Samples

Provide compliance leadership, direction, and oversight in the area of Computer System Validation
Responsible for the quality assurance oversight of GxP regulated computerized systems
Responsible for the release of regulated systems for GxP production use
Develop and maintain computerized system life cycle documentation: user requirement specifications (URS), functional requirement specifications (FRS), design specifications, risk-analysis, traceability matrices, standard operating procedures, installation qualification protocols, operation qualification protocols, performance qualification protocols, validation master plans, and summary reports
Maintains awareness of current regulatory trends and their impact on the validation status of computerized systems. Provide interpretation and recommendations on compliance with FDA / EU Regulations regarding CSV related issues
Oversight software and hardware systems to ensure that validation is correctly and effectively implemented
Provide training on systems implementation and validation SOP’s
Conduct 21 CFR Part 11 assessments on new and existing computerized systems
Conduct System Compliance Risk Assessment
Assess the impact of system changes thru change control system; participate in the planning and implementation of change
Ability to apply complex system validation principles to work assignments
Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering business owners
Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to CSV projects

Validation Manager Resume Examples & Samples

Independent validation of the Internal Model, for both business and regulatory purposes, along with the production of Validation Reports, performed at a Group level and as required to support each XL Catlin legal entity
Develop and maintain a robust validation policy and framework, that independently review the accuracy and appropriateness of the Internal Model
The team also supports
Supervising construction and maintenance of validation tools and summary models
Production of validation output summaries, interpreting test conclusion and escalation of associated findings to the appropriate individuals
Identifying appropriate findings and suggesting future remediation for unexpected validation results
Taking ownership of delivering certain validation reports throughout the year
Assisting in developing and maintaining a robust technical validation framework
Oversight of validation of model changes implemented by the Capital Modelling Team
The individual will be expected to be flexible in their work ethic. This might involve switching from one project to another as priorities change, changing study days or working later than planned
In addition to the key accountabilities above, there will be the occasional requirement to undertake other duties, as the Company requires
The role requires individuals with a mathematical background and substantial experience working in a general insurance company
Bachelor's degree from college or university in mathematics or related field
Being a nearly or newly qualified actuary with at least 4 years of relevant actuarial work experience is advantageous, but not essential. A suitable technical background in another risk management discipline will be considered
Excellent attention to detail and a meticulous eye for identifying inconsistencies or inaccuracies in data entry or data outputs
Ability to establish and follow robust, logical and auditable processes to complete a task or project
Track record of identifying and analysing problems, identifying & evaluating options, deploying sound decision making skills
Able to organise self (and others if applicable) including effective scheduling, prioritisation and time management skills, completing tasks to tight deadlines. Demonstrates a ‘can do’ attitude
Comfortable taking ownership for own work, identifying the need for action (using initiative) whilst working effectively within a team
Excellent computer skills including experience with Microsoft Excel, Microsoft Powerpoint and Microsoft Word
Demonstrates excellent communication skills, a confident and articulate presenter to internal/ external audiences, exercising appropriate discretion in dealing with people from all levels of the Company
Ability to build effective working relationships (internally/ externally), establishing credibility amongst a wide and demanding client group (if applicable)
Knowledge of the Igloo modelling software platform
Demonstrable evidence of interpreting & manipulating data clearly and accurately, with the ability to extract & clearly articulate key points
Displays a resilient and adaptable style, track record of remaining calm in demanding circumstances, adjusting comfortably to changing conditions/ priorities
The role would suit highly driven self-starters, with a strong desire to challenge and deliver
Solid understanding of the insurance business environment, risk management operations and underwriting together with Solvency II exposure
Business acumen – demonstrates sound intuitive judgment

Macos Release Validation Manager Resume Examples & Samples

3+ years experience leading technical and/or test teams in the software industry
Demonstrable experience in developing comprehensive QA plans and executing them to completion
Proven track record in leading development of automation tools
Excellent verbal, written, and presentation communication skills
Must be self-motivated, detail-oriented, and have a high degree of organizational skills
Proven ability to work under pressure, and comfortable working in a fast-paced, cross-functional environmen
Experience in development and/or testing of a shipping product
Regression isolation and debugging experience
Scripting experience (JavaScript, Bash, Perl, Ruby, Python, etc)
Fundamental understanding of operating systems

Quality & Validation Manager Resume Examples & Samples

Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System)
Providing and/or facilitating quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution
Project problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within IT functions, site and local operating company Quality organisations, and Third Party suppliers/service providers
Ensuring issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems
Development, management and reporting of performance measures to drive performance and continuous improvement
Proven ability to manage the validation, deployment, change management, and inspection support of large, complex, computerised systems
Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations
Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerized systems
Proven ability to analyze complex data/information/scenarios and make rational, risk based decisions which are communicated and/or escalated clearly and confidently
Proven ability as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives

Validation Manager Resume Examples & Samples

The role will have oversight of validation systems and functional management of validation execution, coordinating and managing efforts with Manufacturing and QC for execution of process validation, cleaning validation, ancillary validation studies and Continued Process Verification
The role is responsible for the set up and execution of validation studies for the Lengnau site, which is foreseen at the current time to include three dedicated bulk drug substance production lines (100 L perfusion bioreactor to 14,000 L bioreactor fed-batch processes) and a single fill/finish line supporting all three bulk lines. Unique ancillary validation studies for recombinant manufacturing include: limit of in vitro cell age testing, complex comparability assessments on bioreactor cultures, media use testing, cell bank stability testing, etc. The responsibilities include respective documentation preparation activities
The role is responsible for the set up and execution of cleaning validation activities for manufacturing processes at the new Lengnau Site and associated documentation preparation, requiring functional oversight of validation teams populated by Manufacturing, Engineering Services and QM-Validation
The role has active involvement in issue resolution arising from validation activities in cooperation with manufacturing (e.g. deviation handling, change requests)
The role will contribute to implementation of Lifecycle Validation concepts at Lengnau
Ensure actions comply with
Degree (Bachelor, Masters or higher) in Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent

Validation Manager Resume Examples & Samples

Responsible for managing a small team of engineers who will conduct validation studies of major process equipment in vaccines and biologics manufacturing facilities
Develop overall schedules for validation projects and coordinate daily testing schedules for team members. Coordinate thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs)
Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples. Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers, chromatography columns, filter carts, and filter housings
All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout. Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing
Practice highest regard for Safety: Work with potentially dangerous systems, some which utilize high pressures and temperatures
Perform validation review and support for pilot plant campaign and master cell bank readiness plans
Act as Subject Matter Expert (SME) for the validation of commercial product equipment and manufacturing. Possess ability to answer validation questions and interact with various regulatory agencies
Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations’ issues with equipment validated cycles
Conduct out-of-specification (OOS) investigations and author OOS reports
Update and maintain validation SOP’s for conducting all validation work to include: sample preparation, sample collection, sensor calibration, and final report documentation packages
Minimum 10 years of relevant experience in engineering, preferably in the pharmaceutical validation testing discipline
Demonstrated leadership and teamwork skills, excellent analytical abilities, excellent written, and verbal communication skills

Validation Manager Resume Examples & Samples

Validation Experience is essential for this role
Degree in a scientific /engineering discipline or equivalent experience
Experience of leading high performing teams and analytical skills to be able to undertake problem solving and root cause analysis
Track record of engagement in problem solving on issues, with previous manufacturing environment experience
Experience of working with relevant Regulatory bodies and preparation for audits
Understanding of Operational Excellence and GPS ways of working
Pharmaceutical Experience is highly desirable
Experience of project management or supporting large Capital projects
Experience working in and supporting multi-disciplined teams and ability to work with, coach and influence a broad range of staff and management
An excellent understanding of risk assessment techniques
Mange the Capital Validation team, ensuring oversight and delivery of the validation aspects of all capital projects at the Worthing site

Quality Validation Manager Resume Examples & Samples

Establish lean practices around Quality System Software Controls for all shared or local QMS SW systems in line applicable policies and procedures
Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process
Ensure that new software and changes to existing software or infrastructures are validated before approval and use
Ensure documentation of SW validation activities and results for all phases of the software system Life cycle
Understanding of current inspection practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained
Effective judgment and decision making skills, typically made under stressful situations
Competency in project management and the execution of multiple projects
Demonstrated capability in critical thinking and leadership with strong abilities in relationship management

Dimensional Validation Manager Resume Examples & Samples

5+ years of combined experience in project management of tooling and gages, facility and equipment, or dimensional control
Advanced degree preferred in the area of Engineering or Management
General knowledge of Procurement

Ccar / Basel Validation Manager Resume Examples & Samples

Assessing the internal control environment by conducting walkthroughs and performing control and sample data testing
Validating transaction capture through regulatory reporting processes
Analyzing identified issues for their impact on capital and other upstream and downstream processes or systems, as well as communicating and escalating observations
Possesses strong project management and interpersonal skills, makes sound decisions, exhibiting initiative and intuitive thinking
3-5 years of experience

AML Issue Validation Manager Resume Examples & Samples

Assist with developing and monitoring the Line of Business (LOB) BSA/AML Compliance programs to ensure compliance with laws, regulations and corporate standards
Ensures BSA/AML internal controls are sufficient
Makes recommendations to management in regard to risk areas, preventative actions and opportunities for improvement
Monitors business activities, procedures and documentation for compliance with BSA/AML regulations and corporate standards. Researches compliance laws and regulations and provides guidance to the LOB
Conduct issue specific independent control testing of LOB records and internal procedures to ensure compliance with laws, regulations and Bank procedures
Prepare reports for management
Determine potential areas of risks appraise their significance and make recommendations to improve system controls
Considerable knowledge of applicable laws, regulations, financial services, and regulatory trends that impact their assigned line of business
Considerable understanding of the business line’s operations, products/services, systems, and associated risks/controls
Considerable knowledge of Risk/Compliance/Audit competencies

Coherency IP Validation Manager Resume Examples & Samples

Plans, provides resources for and directs activities in engineering function to meet schedules, standards, and cost
Identifies and analyzes problems, plans, tasks, and solutions
Provides guidance on employee development, performance, and productivity issues
Plans and schedules daily tasks, uses judgment on a variety of problems requiring deviation from standard practices
First line management of engineers
Setting goals, schedule and staging plans along with tracking and enabling execution for team
Technical hands-on contributions
Contributing to organizations longer-term technical visions
Strong leadership skills and drive to guide and motivate team
Strong communication skills and ability to influence and work across large teams
4 years technical leadership / management experience
3 years of experience of SV OVM/UVMo 3 years of experience computer architecture
3 years of experience of validation architecture and infrastructure
3 years of experience of stat of the art coherency protocols and interconnect protocols

Validation Manager Resume Examples & Samples

Responsible for creating, executing and enhancing facility, equipment, and utility qualification/validation, cleaning validation, process validation, and computer system validation programs at a, multi-product GMP cell therapy/viral therapy contract manufacturing facility
Ensures that systems and controls for the above activities meet Global Quality standards and applicable regulatory requirements
Develop Validation Master Plans and Project Master Plans. Review completed protocols/reports for completeness, cGMP compliance and acceptability of data
Develop Project Scope for validation activities and assist Engineering and Finance in development of Capital Expenditure Requests
Manage external and internal validation resources to facilitate project completion
Schedule project validation activities and personnel to meet business, manufacturing, engineering and quality objectives
Liaise with clients to ensure that scope, execution and reporting of validation meets their expectations
Participate as required in Regulatory Inspections and client audits
Determines and manages resource requirements to support operations in areas of responsibility. Develops annual budget for group and manages expenses to budget

Validation Manager Resume Examples & Samples

This position will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment
This position will be responsible for developing project scope statements, estimates and proposals
This role will assist in the development of policies, programs and project master planning
This position requires experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously
Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired
This position requires strong leadership, verbal communication, technical writing, project management tools and word processing skills
Minimum of 7 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects
Diverse experience in leading project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable
Project Management experience in managing scope, cost, schedule, quality and risk is required
Experience in team building, mentorship and multi-discipline collaboration
Displayed leadership in a consulting and service environment

Validation Manager Resume Examples & Samples

Manage the assigned engineering validation team
Schedule, plan, and manage routine validation and requalification related to manufacturing facilities, equipment, equipment cleaning, equipment sterilization, utilities, computerized and automated systems
Ensure compliance with regulations, Shire policies, quality practices, and proper documentation
Develop employees and potential leaders within the team
Achieve validation team goals in respect to Validation tasks. Finance, Quality, Fulfillment and EHS
Ensure the development and completion of validation documentation according to quality & regulatory requirements and company policies
Prepare and present difficult topics during audits & inspections and follow up in case of citations related to the validation team
Support investigation of non-conformities (deviations and exceptions)
Drive continuous improvement and implementation of new ideas
Communicate status and validation topics in a clear and concise format
BS or MSc University degree or equivalent in Engineering, Biology, Biotechnology or relevant field
Minimum 5 years of experience leading a small team
Overall relevant work experience of about 10 years, ideally at multi-national level organizations, within the pharmaceutical, biotechnology manufacturing industry
Experience and knowledge of engineering validation
Broad validation knowledge, industrial trends and validation related literature
Solid computer skills including Word, Excel, PowerPoint
Very good English level (oral and written)
Very good French level (oral and written)
Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment
Ability to manage multiple priorities in a manufacturing plant setting
Ability to analyze, review and interpret scientific and validation data
Must have uncompromising dedication to quality and an excellent understanding of CGMPs and other regulatory guidelines
Interpersonal skills that enables you to work with people at all levels
Ability to present information to groups and senior management
Ability to plan, multitask, and manage time effectively
Must display personal accountability for results and integrity
Must display eagerness to learn, to innovate, drive for solutions and continuously improvement

Validation Manager Resume Examples & Samples

Train, develop, and provide leadership to the Validation Engineers to ensure protocols are written, executed, and reported efficiently
Manage the Validation team and select Quality Assurance personnel
Develop and maintain the Validation Master Plan and lead the site in meeting the plan
Provide technical expertise during validations, design reviews, factory acceptance testing, engineering studies, and investigations
Coordinate internal and client validation projects for packaging equipment, processes, facility, utilities, cleaning, and computer systems
Serve as Subject Matter Expert on controlled documentation (batch records, deviations, investigations, etc.), regulatory requirements, technical advances in the field of validation, and the latest industry trends
Bachelor’s Degree required, preferably in Engineering or Science
At least 5 years of Quality Assurance or technical experience in an aseptic or sterile cGMP environment
Broad validation experience within the pharmaceutical industry
A minimum of 3 years of supervisory experience required
Knowledge of cGMP/FDA regulations; experience in regulatory audits desired
Strong leader with demonstrated ability to manage and lead personnel

Validation Manager Resume Examples & Samples

Validation Manager will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment
The Validation Manager will be responsible for developing project scope statements, estimates and proposals
Experience with financial systems, project and client administration and

Validation Manager Resume Examples & Samples

Manages the site validation program ensuring timely execution of all re-validation requirements thru accurate requirements definition and resource planning
Authors, executes, and summarizes commissioning and qualification protocols for GXP systems including equipment/test instruments, utilities, processes, and IT systems
Coordinates the investigation, impact assessment and resolution for all validation and re-validation non-conformances
System owner of the site’s validation program; defines and revises procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations
Establishes key performance indicators in alignment with company and operational goals; maintain and report applicable department and system metrics
Supports new product and capital project teams by defining and coordinating commissioning and qualification requirements
Provides general technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control
Proactively identify, assess, and mitigate operational and organizational risks; escalate key risks and issues
Support development of department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments as needed
Bachelor’s degree in engineering or life sciences and 7-10 years of validation experience in pharmaceuticals or medical devices OR Master’s degree and 5-7 years
Expertise in FDA, EMA, and ICH qualification / validation requirements and creative risk based approaches for meeting and exceeding the minimum requirements
Demonstrated situational leadership skills and project management expertise; ability to plan complex projects and accurately assess and manage resource requirements
Thorough understanding of key supporting quality systems including change control, deviation / non-conformance, and CAPA. Expertise in root cause analysis
Excellent analytical and problem solving skills coupled with strong presentation skills. Excellent communication skills, both verbal and written
Working knowledge using Kaye Validator or equivalent thermal mapping systems
Direct experience in commissioning and qualification of critical utility systems, critical process equipment and computer systems
Direct experience working in an aseptic formulation and fill manufacturing environment
Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment
Working knowledge of statistical concepts and tool

Validation Manager Resume Examples & Samples

Degree or equivalent in a scientific or engineering discipline or equivalent qualified by experience
Demonstrable experience of working within a current Good Manufacturing Practice (cGMP) environment with expertise as a practising professional in Validation
Specialised knowledge and experience of current standards of validation for cell and gene therapy/ biopharms, lab equipment and computer validation, including the validation lifecycle
Thorough understanding of industry standards and best practices in validation area
Knowledge of cGMP regulations and guidelines including but not limited to GAMP 5, U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
Competence in managing multiple validation projects including supervision of junior staff, approval of validation deliverables and maintaining project timelines
Supervisory and leadership skills
Experience of representing validation activities in both internal audits and regulatory inspections
Ability to lead investigations into non-conformances, identifying root cause and delivering effective solutions
Demonstrable experience of line and/or matrix management other team members, able to implement plans and hold self and team accountable for delivering short and medium/long term goals
Ability to train and mentor colleagues involved with the execution of validation activities
Able to provide leadership to generate options in resolving problems, prioritising solutions (and selecting optimal choices) and implementing decisions
Demonstrated use of Operational Excellence (OE) tools
Experience of effectively leading and managing technical, professional teams
Working knowledge of relevant Site systems, e.g. MERPS, CDMS, Trackwise/Charisma 3 , Empower etc
Matrix leadership experience
Train, coach and supervise other validation team members
Plan and resource all validation and lifecycle activities in line with the Cell and Gene therapy strategy and the Site Validation Master Plan
To interface with the engineering and laboratory service providers over the provision of IT service and equipment maintenance provision to ensure all IT updates, equipment calibrations and PMs are completed according to the required routine and specifications
Use a risk based approach for problem solving and prioritization of tasks. To investigate root-cause and solve laboratory equipment issues when these arise, in a timely manner to ensure the downtime of systems is kept to a minimum and all remediation is carried out in compliance with departmental and company procedures
To write, review, approve and implement validation documentation and ensure it is written in accordance with cGMP , local procedures and meets both FDA and MHRA requirements
Lead the Validation Working Party acting as a validation expert to ensure projects are executed to meet regulatory requirements
Represent CGT for all aspects of equipment and software validation during internal audits and regulatory inspections
To participate when required in the change control process with regard to new equipment installation, changes and decommissioning. Ensuring change controls are raised and plans are created, and tasks completed on time
Act as SME during the investigation of quality incidents and establishment of CAPA related to validation or use of equipment and software
Advise GSK CGT and vendors on suitability and required standards / functionality of new equipment/systems during the selection process
Review and approve validation documentation generated by validation team members for equipment and facilities including Periodic Validation Reviews
Write, review or approve departmental documents subject to regulatory agency review, including validation master plans, specifications, protocols, final reports, change requests and validation reviews

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