Manager, Validation Resume Samples
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Manager, Validation Resume Samples
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KB
K Bayer
Kylie
Bayer
835 Schultz Parks
New York
NY
+1 (555) 383 4442
835 Schultz Parks
New York
NY
Phone
p
+1 (555) 383 4442
Experience
Experience
Los Angeles, CA
Manager, Validation
Los Angeles, CA
Smith LLC
Los Angeles, CA
Manager, Validation
- Manage the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees. Responsible for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information./automation validation
- Manages the Validation group to provide technical support and direction to the Process Quality Control organization and to Manufacturing Engineering. Interfaces with Regulatory agencies in conjunction with new drug applications, facility inspections, field complaint investigations and technical interchanges to represent the company position with respect to validation and quality control issues
- Reviews and/or recommends actions with respect to the investigation of manufacturing deviations and the disposition of nonconforming product. Responsible to hire, develop, promote and discipline Validations personnel
- Reviews and approves validation and test protocols for adequacy and completeness. Approves and authorizes product and manufacturing process changes based on review of information, test data and reports
- Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems. Manages and controls validation documents for the Technical Services Department
- Provides overall direction and expertise for administration of validation/revalidation policies in compliance with Quality System Regulations and corporate policy
- Ensures that work is performed in compliance with cGMP, GDP, GLP, SOPs and established corporate policies and standards
Boston, MA
Validation Engineering Manager
Boston, MA
Graham, Grimes and Rath
Boston, MA
Validation Engineering Manager
- Manage team development through training, coaching and career mapping; develops personal growth opportunities
- Provide consultation to other departments and sites performing validation activities
- Provide regular reports to management
- Development of validation planning and test monitoring tools to provide actual status of validation testing to project teams
- Provide leadership and direction to the Validation Engineering team to accomplish all team goals and objectives
- Ensure complete validation support is provided to meet department and company goals in sustaining existing products and the introduction of new ones
- Coordinate with end users and process owners to lead development of validation protocols
present
Phoenix, AZ
Senior Manager, Computer System Validation
Phoenix, AZ
Gibson LLC
present
Phoenix, AZ
Senior Manager, Computer System Validation
present
- Direct the computer system validation of automation system related projects from internal staff and contractors
- Maintains staff by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, work environment; developing personal growth opportunities
- Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, developing, coordinating, and enforcing systems, policies, procedures, and productivity standards
- Develop qualification project plans, deployment plans and test plans
- Develop computer system validation test documentation
- Lead risk assessments to determine testing strategies and scope for automation related projects and changes
- Work with internal and external customers to identify and implement improvements within the Technology department related to system development lifecycle (SDLC) and change management business processes
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
University of Pittsburgh
Bachelor’s Degree in Engineering
Skills
Skills
- Expertise in manufacturing Quality Control, Validation/Quality Engineering and industrial statistics
- Demonstrated ability to handle multiple complex tasks and make timely/appropriate decisions with respect to product quality, compliance and the customer
- Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment
- Excellent verbal, written and interpersonal communication skills
- Knowledge and understanding of validation and qualification principles, project management, and change control principles
- Excellent verbal, written, and interpersonal communication skills are essential. Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations staff
- Demonstrated ability to manage a multi-disciplined technical staff
- Excellent telephone and written communication skills with proven prior experience
- Working knowledge of US regulatory submission
- Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities
15 Manager, Validation resume templates
Read our complete resume writing guides
1
Manager, Computer System Validation Resume Examples & Samples
- Validation oversight of all Global ERP related activities
- Developing validation strategy for specific computer system implementation projects
- Providing up-front assessments of validation scope, timeline, and budget and presenting to project stakeholders and management
- Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will produce the most value
- Manage consultants to ensure that project timeline, budget, and quality are maintained
- Act as the process owner for elements of the validation policy as assigned
- Present information to regulatory, partner, and internal auditors are required
- Working closely with Information Technology, Quality Assurance and system owners to effectively and efficiently implement new systems, system upgrades, or system modifications
- Actively participates in the Computer Validation Forum to ensure that relevant information is shared cross-functionally
- Assisting with design of computer validation testing in coordination with BioMarin policy and procedures
- Assist in development, implementation, and execution of computer validation policies and practices by identifying process improvements
- Participation in the change control program for modifications to qualified systems
- Coordination between internal departments, including Manufacturing, Information Technology, Quality Control, Quality Assurance, Corporate Compliance, Facilities, Technical Operations and Research & Development and others
- Represent IT-CSV at meetings involving CSV topics (e.g., site inspection readiness meetings, IT project steering committee meetings)
- B.S. in a science, computer science, or engineering discipline
- 6+ years experience in a GxP environment, with 4+ years of experience in a computer validation function
- Minimal supervisory experience is a plus
- 5+ years’ experience working in Computer Systems Validation
- Experience with ERP Systems required, Oracle EBS R12 preferred
- Experience with HP Quality Center or equivalent software testing/requirements tools desired
- Good organizational skills
- Experience in coordination contract staff, and/or experience in project management
- Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements
- Must possess a thorough understanding of current industry guidance, including GAMP 5
- Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects
- Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them
- Ability to present and defend validation data to a small group
- Experience in DeltaV, ERP, LIMS, EDMS, CMMS, QMS, and Laboratory Systems are highly desired
- Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point)
2
Validation Test Manager With Life Sciences Domain Resume Examples & Samples
- Oracle Agile PLM
- Serialization
- Regulatory Applications
- Oracle EBS
- Veeva or Salesforce or other SaaS Applications
3
Manager Capa & Validation Resume Examples & Samples
- A Bachelor of Food Science/Chemistry/Quality/Engineering or a Third level qualification in a related discipline
- Very good understanding of the manufacturing process
- Strong knowledge and experience in analytical techniques and methods used
- Excellent interpersonal skills and management skills
4
Cgmp Manager Quality Validation Resume Examples & Samples
- Writing
- Balanced Decision Making
- Negotiation/Influencing
- Detail Oriented
5
Manager, Validation Resume Examples & Samples
- Conducts activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to this role. Completes all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Reports potential issues of non-compliance
- Ensures and monitors compliance by team members and third parties by a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, b) ensuring completion of all required training, c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and d) immediately addressing and reporting, as appropriate, instances of non-compliance
- Manager accountabilities at Astra Zeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness
- Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality System and continually improve its effectiveness
- Bachelor's degree required, preferably in Chemistry or Industrial Pharmacy
- Strong understanding of cGMPs, demonstrated leadership, management, and technical capabilities
- Demonstrated applied knowledge of ICH guidelines Q8, Q9, and Q10, statistical process control, and PAT
- Excellent verbal, written, and interpersonal communication skills are essential. Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and operations staff
- Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives
- Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects
- Knowledge and understanding of validation and qualification principles, project management, and change control principles
- Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment
- Demonstrated ability to manage a multi-disciplined technical staff
- Master's degree is highly desirable
- Six Sigma green belt or equivalent experience is preferred
- Experience with IQ/OQ/PQ and Lean Manufacturing is highly desirable
- Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable
6
Senior Manager, TQM Validation Resume Examples & Samples
- Proven Line Management or Leadership experience
- Quality Assurance experience
- Clinical research experience is preferred
7
Validation & Verification Test Manager Resume Examples & Samples
- Engineer, preferably in telecommunications
- 5 years experience of Telecommunications system Integration and testing
- Experience in Customer Management
- Demonstrable management style
8
Bios Validation Program Manager Resume Examples & Samples
- Bachelor's Degree in a relevant engineering field; Electrical, Computer, Technology
- 0~5 years relevant work experience performing in a demanding/schedule driven R&D environment,
- Knowledge of computer and BIOS architecture,
- Knowledge of Intel and AMD chipset and microprocessor architecture, technology, features, and designs,
- Familiarity with validation methodology, processes, and tools
- Ability to exercise independent judgment, work within defined policies and practices, determine best method for accomplishing work and achieving objectives
- Appropriate project management skills necessary to successfully deliver project qualification objectives while effectively engaging with ODM partners,
- Applies appropriate risk management skills - understands risk concepts, assesses risk qualitatively, and uses relevant techniques to measure performance and progress of ODM partners in order to mitigate risk to deliverables,
- Strong commitment to excellence, dedication, team player, self-motivation, and with good communication skills
- Must have good English communication skills (verbal and written)
9
Iphone Hardware Validation Project Manager Resume Examples & Samples
- Positive attitude, even under pressure
- Passion for shipping high volume, fully validated products
- Schedule driven, desire to help other people be schedule driven as well o Fearless organizer and task driver
- Enjoy a fast paced environment
- Systems thinker: experience in developing systems
10
Senior Manager, Validation Resume Examples & Samples
- Manages all aspects of the Validation Department in accordance with current guidelines on equipment, utilities, and facilities validation, in compliance with pertinent regulations (e.g., FDA, EMA)
- Assesses overall validation workload, staffs accordingly, and deploys resources to attain Manufacturing Engineering & Facilities (MEF) and production goals. Manages and tracks the execution of all relevant validation activities within the Manufacturing and Laboratory areas, integrating their timeline with ongoing projects and programs
- Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules
- Interacts with people from all departments to resolve issues
- Manages a team of validation personnel, including training, developing, coaching, and addressing personnel issues
- Coordinates participation on Tech Transfer, and cross-functional teams including global Validation,, CMC, start-up
- Works to ensure Validation organization receives the emphasis and resources required to achieve site and corporate goals
- Presents and defends validation systems to Regulatory Inspectors
- LI-POT4
- A minimum of eight to ten (8 - 10) years related experience and/or training; or an equivalent combination of education and experience
- Practical knowledge and application of GMPs, GLPs, and EMEA and ISO regulations
- Experience dealing with FDA investigators, authoring responses to critical, major or minor observations and implementing corrective measures
- Experience in coordinating / leading cross-site or cross-functional initiatives
- Proficiency in, MS Word, MS Excel, and MS PowerPoint
- Requires excellent oral and written communication skills
11
Manager, Validation Resume Examples & Samples
- Provides leadership and training to the Validation Team members
- Develops and manages all validation policies, procedures, and protocols
- In conjunction with Quality Assurance, establishes corporate guidelines related to validation and quality issues and programs
- Coordinates validation project schedules
- Provides assistance, as required, to meet departmental and organizational goals and objectives
- Reviews and approves the validation documents developed and executed by the validation staff
- Participates / Presents (as needed) validation projects to the FDA and other customer regulatory groups
- Participates on and/or leads project teams working with all groups within Alkermes on design and implementation of new equipment and systems, changes to existing equipment and systems, facility expansions, implementation of new and transferred projects, and process optimizations
- Develops and executes project management activities for validation projects
- Evaluates compliance related issues and participates in the development of action plans to correct deficiencies, as necessary
- Ensures that work is performed in compliance with cGMP, GDP, GLP, SOPs and established corporate policies and standards
- Participates in Technology Transfer of new products
- As appropriate, authors, reviews and approves SOPs and other controlled documents
- Directs validation staff to ensure continuous improvement
- Ensures thorough training and development of the Validation Team members
- Establishes policies, standards, templates and recommended procedures in all areas of validation
- Provides validation support to other functional areas
- Maintains current awareness of industry and regulatory activities pertaining to validation
- Promotes communication at all levels and makes information available when and where needed
- Displays enthusiasm and initiative
- Capable of communicating at all levels of management
- Maintains professional working relationship with co-workers and staff
- Superior interpersonal skills and ability to work effectively in a team environment
- Assists Director of Validation in meeting departmental goals and objectives
- Manage the daily operations of the validation department, which includes hiring, staffing, development and monitoring of a budget, completion of performance evaluations on a regular basis, and completion of required reports
- As needed, writes and executes protocols for IQ, OQ, and PQ validation for plant processes and utility support; process validation; cleaning validation; process cycle development and process development; and computer validation using System Development Life Cycle approach. Writes final summary reports for above listed protocols
- Provides technical assistance as required for all groups within Alkermes
- Interprets company policies to employees and enforces safety regulations
- Adheres to and administers all company policies and procedures
12
Manager, Validation Resume Examples & Samples
- Manage the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees. Responsible for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information./automation validation
- Develop, approve, execute, and present all validation master plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs
- Negotiate the scheduling and commitment of specific resources outside the department required for validation projects
- Coordinate the audits of inter-departmental validation programs
- Manage multi-disciplinary validation teams, approve testing protocol and establish acceptance criteria for validation projects that impact on the production and control of externally produced products, both in clinical supply and trade product manufacturing
- Audit, evaluate, and qualify all vendors or contractors. Negotiate validation requirements with these vendors. Plan and establish technical communications, document flow, testing requirements, and financial resources necessary to produce the validation of the system. Review and approve all vendor-supplied documents
- Select bidders, award and administer contracts involving in excess of $1.0 million for consulting, laboratory, and process validation engineering services
- Represent the department during audits, meetings, and teleconferences regarding process validation issues with the FDA. Provide responses to FDA deficiency letters and audit observations
- Participate in project team activities and process design to insure CGMP compliance as the validation representative on engineering project teams
- Develop and maintain a plant wide change control system to review, authorize and document changes to validated systems
- Provide process validation guidance to domestic contractors and other subsidiaries of the Company supplying US markets regarding current FDA requirements for facility and product approval
- Determine FDA’s current regulatory and enforcement policies regarding process validation of drug manufacturing for domestic and foreign sites and implement procedures accordingly
- Represent the Company as an active participant on internal (GQD) and external (ISPE/PDA/PMA) professional committees establishing policy guidelines relating to validation issues
- Prepare and defend five-year plans and annual budgets for the department by assessing manpower and capital needs
- It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace
- Comply with all job-related safety and other training requirements
13
Manager for AML Scenario Management & Validation Team Resume Examples & Samples
- Supervise and/or conduct data-driven analysis and reports. Apply qualitative and quantitative data analysis methods. Validate data, identify data quality issues (if any) and address them. Apply rigorous statistical methods to organize, analyze, and interpret data and reports; ensure appropriate methodology is selected to draw conclusions and make recommendations answering specific business needs
- Build an effective team assuring capacity to address business needs. Identify and develop talents and prepare succession plans for key positions in the team
- Coach and supervise juniors, give directions, ensure the quality of analysis and work done and raise the standard of juniors to the next level of excellence and maturity
- Use visualization techniques to display data and the results of analysis in clear straightforward presentations that can be understood by non-technical readers. Provide written explanations of approach and analysis in plain language that supports the conclusions and observations
- Drive quality, reliability and usability of all work products. Evaluate and refine the statistical methods and procedures used to obtain data in order to ensure validity, applicability, efficiency, and accuracy
- Innovate and generate new ideas, concepts and models to improve methods of obtaining and evaluating quantitative and qualitative data. Identify relationships and trends in data, as well as any factors that could affect the results of research. Question and validate assumptions and status quo. Escalate identified risks and sensitive areas in terms of methodology and processes
- Think outside the box and look for new methods to constantly improve the effectiveness and efficiency of the AML Detection, Monitoring and Operations systems and processes used in Citi
- Document solutions and present results in a simple comprehensive way to non-technical audience, as well as write more formal documentation using statistical vocabulary
- Strong statistical/data analytical skills, including data quality validation, descriptive statistics and predictive modeling experience
- Minimum of 4-5 years of experience with statistical software packages such as SAS, SPSS, etc
- Knowledge of some programming languages (preferably SQL and/or 4GL)
- High proficiency in MS Office, especially MS Excel
- Required experience with relational databases such as Oracle, SQL Server, and Data Marts/Data Warehouses
- Minimum 4-5 years of relevant experience in large, complex environments
- Mantas, AML monitoring systems and Spotfire experience a plus
- Experience in managing a team is preferred
- Demonstrates a strong understanding and application of analytical techniques
- Ability to effectively communicate, both orally and in writing, through all levels of the organization
- Self-motivated with the ability and maturity to make decisions in the absence of detailed instructions
- Methodical analysis and problem-solving skills
- Able to coordinate and deal with various level and conflicting time demands
- Master degree in statistics/mathematics/technical science
- Degree in economics/banking may be considered if strong analytical skills proved
14
Manager, Analytics & Validation Resume Examples & Samples
- Provide leadership and technical expertise to the DVC product teams and DVC
- Demonstrated interactive skills, planning skills, presentation skills, and exhibit strategic
- 10 years relevant work experience or a Bachelor’s degree and 15 years relevant work
- Extensive experience in analytical development of methods used for testing of biological
- Understanding of analysis skills, including the application of Design of Experiments (DOE),
15
Program Manager Analog Test & Validation Resume Examples & Samples
- Program management degree is a plus
- Strong knowledge and hands on experience in project/program management
- Strong understanding of pre and post Si development processes, flows and deliverables
- Knowledge in electrical circuits design fundamentals, manufacturing flows, and platform validation operations
- Strong communication, presentation and leadership skills
- Ability to collaborate across multiple organizations and across geos
16
Project Manager, Product Validation Resume Examples & Samples
- University degree in sciences as: Engineer (civil, chemistry, biochemistry, agronomy) or Pharmacist
- At least 5 years’ experience in vaccine production including knowledge of new production technologies, in particular Packaging
- Experience in a matrix organization is an asset
- Expertise in validation, knowledge of International standards (CFR and Eudralex), GMP and Regulatory
- Expertise in RA and prior approval establishment RA inspections
- Responsible for the coordination of the validation of raw material projects
- Responsible for ensuring the coordination (planning, weekly validation committee participation) of projects from the Basic design step to the RA file approval in EUR or US
- Responsible for performing the writing of the facility submission files for the projects, including the update of MOP
- Responsible for participating, for change control and raw material sections, in external authorities inspections (EMEA, FDA, WHO, AFMPS…)
- Responsible for assuring inspection readiness – regarding raw material projects and change control process – by Corporate GSK functions and RA authorities (FDA, EMEA)
- LSPOC Change Control, he/she is the referent of change control process for the Packaging MPU
- Complaint management, responsible for the management of complaint process within Packaging MPU. (response to global functions and quarterly report)
- Management of raw material issue, ensure that all issues from the production are treated in collaboration with the following departments: TLCM, QA IM and Procurement
- SPT (Site Product Technologist): management of artwork and approval of specifications and drawings of raw material
17
Manager Expert Produit Validation P&P Resume Examples & Samples
- Product and process expert. Knowledgeable in fermentation, extraction and purification of antigens. Quality control knowledge and in-depth understanding of process parameter, process evaluation and validation in a GMP environment. Fluent in English and project management skills. Scientific background and investigation skills. Knowledgeable in change control management including implementation and execution. - At least 7 years’ experience in fermentation processing or vaccine production including knowledge of the scale up principles, quality control tests and in new production technologies
- Experience in a complex / matrix organization
- Work ExperienceRequired
- Engineer in chemistry, biochemistry, or agronomy, Pharmacist
- Expertise in pharmaceutical aseptic production or expertise in validation or QA
- Leading/Managing change - Designing and implementing change projects to improve business performance. Guiding a team through a period of change providing support and direction
- Experience Level
- Provide scientifically sounded product impact assessment in complex deviation
- Manage product & process control monitoring and trending
- Manage product characterization
- Drive continuous improvement project
- Address regulatory technical request
- Provide expertise and coaching to production team
- Address product complaint investigation
- Lead product & process task forces
- Assure Product consistency and annual product review
- Develop capability & talent
18
Manager Validation QC Bacteriology Resume Examples & Samples
- Bio-engineer or University degree in Microbiology or equivalent acquired through experience, phD is a plus
- Good knowledge in general microbiology and associated pharma industry testing (Bioburden, Sterility, Endotoxins, Disinfectant efficacy, Mycoplasma…)
- Good knowledge in microbiology test validation principles. Rapid Microbiology methods is a plus
- Good knowledge of GMP for biologicals products
- Good level of written and spoken English
- High level of flexibility, sense of priorities, communication and good organisationnal skills
- Lean culture knowledge is a plus
- Motivates and encourage teams of technicians to achieve maximum productivity with good management of priorities
- Provide technical support to direct reports and is Single point of contact for Microbiology validation activities within department (Central Quality Control) and for stakeholders
- Organization and monitoring of performance progress efficiency of the team through performance indicators releated to Quality, Cost, Productivity, Security for example
- Ensuring compliance of the operations with GMP and Authorities requirements in collaboration with QA
- Apply GSK processes and Pharmacopeia requirements
- Manage EHS aspects
- Anticipate potential improvements, Implementation of correctives and preventives actions
- Deviations management
- Change control management
19
Manager, Systems Analysis & Validation Resume Examples & Samples
- Work collaboratively with IT teams, internal business partners and external vendors to identify, understand, implement and support new business capabilities
- Provide business analysis support on all phases of the IT systems development lifecycle (SDLC) with an emphasis on requirements gathering, specification documentation, and software testing
- Leading business and technical owners in defining use cases, business process flow, design, and generating test documentation
- Serve as a computer systems validation (CSV) lead, subject matter expert, and/or resource on project teams to plan, execute and deliver validation projects following the Jazz CSV framework
- Manage vendor/contract resources in creating CSV deliverables, and delivering GxP systems following Jazz CSV framework
- Present validation packages to regulatory authorities and internal audit teams during inspections
- Recommend process improvements and incorporating them into IT procedural documents and work practices
- Train project team on current IT policies and procedures, and collaborate with the team to incorporate these processes throughout the project as applicable
- Bachelor degree in Science, Computer Science or equivalent experience required
- 5+ years of enterprise systems analysis experience including requirements analysis, use case generation, design analysis and software testing
- Demonstrated expertise in Computer system validation, and Software Development Life Cycle (SDLC) Management methodologies
- 5+ years in depth knowledge of pharmaceutical regulations including 21 CFR Part 11, EU GMP, GAMP 5, and Annex 11
- Working knowledge of general business processes around R&D, clinical, regulatory, manufacturing, and quality
- Results oriented, and able to effectively execute on projects with minimal supervision
- Strong attention to details, highly organized
- Strong work ethic with a flexible and adaptable approach
- Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment
20
Product Validation Project Manager Resume Examples & Samples
- Maintain and communicate project issues and timing status, and alert management to significant issues or roadblocks
- Proactive support for quality and reliability investigations to identify failure modes, root cause analysis, suggested fixes
- Interface effectively with support groups and internal customers such as design engineers, manufacturing, etc
- Participate in risk assessment, DFMEA, Design reviews to drive design validation requirements
- Contributes to the decrease of overall product warranty activity
- Contributes to customer satisfaction
- Minimum Bachelor's Degree in Agricultural, Mechanical, Electrical or related Engineering field
- 6 years of Experience in mechanical and hydraulic troubleshooting and diagnostics or a related field
21
Validation Engineering Manager Resume Examples & Samples
- Provide leadership and direction to the Validation 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; develops personal growth opportunities
- Define and manage validation strategies for all areas of validation, based on business needs
- Provide consultation to other departments and sites performing validation activities
- Learn and understand the technology and engage in technical discussions
- Ensure complete validation support is provided to meet department and company goals in sustaining existing products and the introduction of new ones
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports. Coordinate with end users and process owners to resolve any identified issues to bring validation to acceptable levels
- Ensure validation activities meet requirements of FDA and ISO
- Provide regular reports to management
22
Validation Test Manager With Life Sciences Domain & Oracle EBS Resume Examples & Samples
- 9 - 12 years of Experience in Life Sciences, Computer System Validation
- Must possess hands on experience and understanding of
- GAMP 5 Risk Based Validation
- Functional Risk Assessment
- GXP Assessment
- 21 CFR Part 11 Assessment
- Data Migration Qualification
- Disaster Recovery Qualification
- Qualification and Commission
- Validation coverage in IQ, OQ and PQ
- Deviation management process
- CAPA
- Validation Summary Reports
- Knowledge on Infrastructure IQ & qualification
- Must have experience in Oracle EBS, SCM / OTC / P2P
- Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
- Must possess formal training/certification on Testing & Validation
- Should be able to work independently with minimum supervision
- Should have worked in cross-functional environments and comfortable to liaison with business
23
Validation Test Manager With Life Sciences Domain & Opsm Resume Examples & Samples
- 9 - 12 years of Experience in Life Sciences, Computer System Validation
- Must possess hands on experience and understanding of
- GAMP 5 Risk Based Validation
- Functional Risk Assessment
- GXP Assessment
- 21 CFR Part 11 Assessment
- Data Migration Qualification
- Disaster Recovery Qualification
- Qualification and Commission
- Validation coverage in IQ, OQ and PQ
- Deviation management process
- CAPA
- Validation Summary Reports
- Knowledge on Infrastructure IQ & qualification
- Experience/practical understanding of OPSM (Oracle Pedigree Serialization Manager) testing
- Good functional knowledge on Oracle Inventory, and Manufacturing modules especially of Oracle Process Manufacturing
- Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
- Must possess formal training/certification on Testing & Validation
- Excellent technical writing skills
- Should be able to work independently with minimum supervision
- Should have worked in cross-functional environments and comfortable to liaison with business
24
Manager Validation Resume Examples & Samples
- 3 years of experience in a supervisory or management role, or leading teams or projects
- Demonstrated strong understanding of Quality systems
- Experienced leading Validation teams to maintain adherence to a validation schedule
- Experienced working with cross-functional teams, including Quality, Manufacturing, Manufacturing Technical Support, Facilities and Engineering and Validation
- Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, validation protocols and other controlled documents
- Working knowledge of GMPs, ICH Q8, Q9, Q10 and other international regulatory requirements
- Application of risk based approach to validation (FMEA, PHA, etc.)
- Must be people oriented and a team player
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio
- Experience supporting internal and external audits and oversee closure of all gaps identified during the audits
- Energetic in the pursuit of improved processes and ultimately improved performance
25
Manager, Validation Resume Examples & Samples
- Working knowledge of US regulatory submission
- Proficient with computer programs desirable; or an aptitude to learn computer programs as needed
- Resourceful and well organized
26
Engineering Group Manager Validation Resume Examples & Samples
- Lead, mentor and manage a team of engineers responsible for validating the components and / or the sub-systems necessary for automated driving
- Work with suppliers in developing the process and procedures necessary to validate components for automotive use
- Provide technical leadership and risk assessment of component test procedures and assist with issue resolution for product weaknesses discovered during validation testing
- Manage coordinated bench hardware testing and simulation as necessary to support and execute sub-system validation testing
- Align sub-system testing to support the functional roll out of software
- Identify & lead staffing initiatives for the team, prioritize work based on available resources, and forecasts future growth
- Manage the overall engineering execution with other departments, functions, and suppliers
- Translate business objectives to actionable deliverables for the team, such as cost, quality and timing targets necessary for a successful program
- Lead initiatives to automate test procedures and develop the new tools necessary for sub-system validation
- Train, develop, and manage the performance of team members to thrive in a high performance workplace
- Translate new and invented processes and test methodologies back into corporate standard work
- Review and approve engineering documentation
- Model and foster winning behavior and excellent core values
- Strong understanding of the GM vehicle development process
- Prior Release or Development / Validation experience with Electronics, Software & Controls or full vehicle electrical systems
- Ability to thrive and lead others when operating in an environment with a high degree of ambiguity
- Track record of success in leading projects and/or people
- Ability to identify and remove roadblocks and excellent conflict resolution
- Excellent conflict resolution skills
- High level of interpersonal skills to work effectively with others, motivate employees, and inspire!
- Ability to create and maintain an environment that enables team members to grow to their full potential
- Strong problem solving ability
- Excellent leadership, communication, and interpersonal skills, specifically
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Manager, Validation Resume Examples & Samples
- Provide leadership, manage, schedule, coordinate, direct, and review the activities and work assignments for Validation Engineers
- Develop, publish and maintain an effective Site Validation Plan
- Initiate, review, or complete documentation as required. Documentation includes but is not limited to the following: Batch Records, MPIs, SOPs, Work Instructions, Quarantines, Investigations, Deviations, Validation Protocols, Customer Complaints and Training Records
- Drive both substantial and incremental improvements in quality systems, business systems and processes
- Effectively communicate with customers and regulatory agencies regarding validation issues
- Ensure Validation staff is trained and up-to-date on validation techniques, requirements, and best practices
- Researches governmental regulatory requirements on each assigned project to ensure that each study subject is challenged to meet required specifications
- Serve as technical expert responsible for being current on the latest industry trends, regulatory requirements, and technical advances in the field of validation
- Maintains close contact with Business development, Engineering, and Manufacturing groups to assure effective communication on challenges and opportunities related to validation
- Develop staff to increase teamwork, individual capability and organizational flexibility
- Subject Matter Expert (SME), reviewer, or approver of controlled documents within area(s) of expertise
- Works directly with management, contract customers, and/or contract engineers
- Provide support as needed for customer and regulatory audits
- Maintain effectiveness of the Quality System components relevant to this position
- 5 years QA or Technical experience in a cGMP environment preferred
- 3 years of supervisory experience required
- Knowledge and experience in cGMP/FDA regulations. Experience in regulatory audits desired
- Demonstrated ability to manage and lead personnel
- Demonstrated ability to handle multiple complex tasks and make timely/appropriate decisions with respect to product quality, compliance and the customer
- Strong math (statistical), root cause analysis and troubleshooting skills
- A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.)
- Demonstrated experience in handling and responding to customer complaints and inquiries
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Senior Manager, System Validation Resume Examples & Samples
- Managing the test activities inclusive of setting up the test infrastructure, executing tests, providing test status & detailed test reports, and assisting development engineers in defect isolation and resolution
- Drive use of standard tools and push for process improvement where possible
- Evaluate test methodologies to reduce test time and increase test coverage
- Work closely with the development team to optimize the development and validation cycle time
- Assesses and advises on the practicality of testing process alternatives
- Identifies improvements to the process and assists in their implementation
- Ensures that any risks associated with the agreed test strategy and the system test plan are clearly documented and described to the clients/users and colleagues
- Manages all risks associated with the testing and takes preventative action when any risks become unacceptable
- Plans, arranges and controls meetings, workshops and relations with client/staff during test planning and throughout subsequent development and testing activities
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Senior Manager, Validation Resume Examples & Samples
- Management of validation staff that provides oversight to, and executes, the validation program. Provides mentoring and coaching of the staff and is focused on personnel development
- Manages all aspects of the Validation Department in accordance with current guidelines on equipment, automation, utilities, facilities, and cleaning validation, in compliance with pertinent regulations (e.g., FDA, EMA). Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules. Ensures global procedure alignment with QMS
- Assesses overall validation workload, staffs accordingly, and deploys resources to attain Engineering and production goals. Manages and tracks the execution of all relevant validation activities within the Manufacturing areas, integrating their timeline with ongoing projects and programs
- Coordinates participation on Tech Transfer and capital projects. Commissioning
- Presents and defends validation systems to Regulatory Inspectors and outsourced partners
- 10+ years total experience in the areas of GMP validation, manufacturing, engineering or facilities in a pharmaceutical environment
- Collaborative attitude with the willingness to work with global peers toward company and department goals. Focused dedication with the willingness to do what it takes to get the job done
- Excellent communication and presentation skills (oral and written)
- Experience negotiating with and managing contractors, vendors, and/or outsourced services
- Ability to organize personal tasks and concurrently monitor direct reports tasks / assignments
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Validation & Verification Manager Resume Examples & Samples
- Manages a team of ~10 Hardware and Software Test, Verification and Validation Engineers responsible for conducting white and black box testing as well as formal design verification and validation
- Develops new and improves existing work instructions and templates to support the product development process, particularly regarding design verification and validation, to improve quality, streamline usage, etc
- Reviews and approves user needs, design inputs, test procedures and reports, and other related deliverables based on project requirements
- Partners with Project and Product Management to address issues found throughout the development lifecycle
- Partners with hardware and software development teams to coordinate testing of software products, including automated software testing
- Recommends design changes that may result in reduced cost or improved quality
- Ensures department associates are trained in and following best practices and have the tools and processes necessary for their tasks
- Administrates the requirement and test traceability tool (Jama) and adds new functionality as required
- Executes other duties and responsibilities as assigned
- Results Orientation - Must be highly driven to achieve results and aggressively identify and solve problems that can impact the scheduled delivery of products. Must be capable of getting to root cause and implementing corrective actions and contingency plans
- Sense of Urgency - Must be accustomed to effectively managing unforeseen situations with quick analysis and decision making
- Motivational Characteristics - This position requires high energy and an unsurpassed drive to win – Every Time! This position must encourage continually improving performance from the team
- Teamwork - Must be willing and able to work closely with other departments, peers, etc
- Communication - Must be able to effectively communicate in both written and verbal forms
- Bachelor of Science degree in Engineering or another technical discipline from an accredited university
- 7-10+ years of overall experience in a fast-paced environment, preferably in the medical device or another regulated industry, with 2-3+ years of successfully leading others
- 5+ years of experience in V&V / Test Engineering in simulated and actual use environments along with experience in an Agile software development lifecycle and automated software testing
- Knowledge of ISO and FDA regulations, specifically regarding Design and Change Controls and documentation standards
- Experience in a formal toll gate /phase gate product development lifecycle environment
- Experience with X-ray source and detector technologies preferred
- Knowledge of IEC 60601 and FDA 510(k) regulations preferred
- Able to work effectively both independently and in a team environment
- Able to prioritize multiple projects and commit to deadlines
- Outstanding problem solving, quick and penetrating mind - can learn a new environment quickly
- Manage “down and in” as well as “up and out,” and identifies and communicates the key priorities to the organization while remaining focused
- Innovative thinker – fosters an environment of creativity, ability to capture and convert ideas to intellectual property
- Strong Danaher values (“walks the talk”), and is pragmatic in dealing with the real-world problems and pressures of new product development
- Fosters cross-functional problem solving and cooperation
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Senior Manager, Validation Resume Examples & Samples
- Manage staff and workload of at least one validation supervisor and 3 - 6 validation specialists and numerous contract validation specialists. Provide direction, coaching and mentoring for routine and complex activities
- Development and implementation of strategy and policies related to Validation. Development and oversight of the execution of Validation related documents throughout the system lifecycle, including development of a comprehensive Validation master plan covering equipment, utilities, sterilization, cleaning , aseptic processing, cleanroom qualification and computerized system validation
- Support change control, investigations, and PR’s, VMP’s and SOP updates. Determine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management
- Represent the validation group and defend policies, program, and validation documentation during audits, regulatory inspections Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure. Provide validation expertise for issue resolutions to support deviations or CAPAs. and audit findings
- Develop and approve cGMP documents including, but not limited to, Master Validation Plans, SOPs. Protocols and forms to improve validation efficiencies
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates
- Minimum 10 years validation experience in a FDA regulated drug or biologics manufacturing facility. At least 5 years management experience or a Master’s degree or equivalent experience in life sciences or engineering with a minimum of six (6) years validation experience in the pharmaceutical or biotechnology industry, and at least 5 years management experience
- Experience in successful management of complex validation projects and authoring and/or reviewing validation documents
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred. Comprehensive knowledge of Validation lifecycles for Computerized Systems and Process Control Systems and aseptic processing, sterilization validation, Cleaning validation and equipment and utility validation
- Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500, and data integrity requirements
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic. The ability to interface and communicate directly with clients may be required
- Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects. text
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Ccar / Basel Validation Senior Manager Resume Examples & Samples
- Cultivating relationships with senior key stakeholders across several departments
- Analyze identified issues for their impact on capital and other upstream and downstream processes or systems, as well as escalating these issues to senior management
- Ability to organize and present data in a meaningful way, including analyzing and summarizing detailed information from various sources
- Strong written, communication, and presentation skills, including the ability to liaise with and influence senior subject matter experts
- Strong quantitative and qualitative analytical skills
- Advanced Excel, Word, and PowerPoint skills
- 7+ years of prior audit or consulting experience
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Manager, Validation Resume Examples & Samples
- Manage the validation program for existing and new products, manufacturing processes, testing, packaging, facilities and utilities. Ensures compliance with Federal Regulatory requirements
- Provides overall direction and expertise for administration of validation/revalidation policies in compliance with Quality System Regulations and corporate policy
- Implements industry standards & functions as the authority on validation strategy, procedures and techniques and regulatory compliance
- Provides direction and participates in validation protocol development/review and approval
- Conducts or directs the conduct of product performance and manufacturing process experiments, studies and tests
- Analyzes or directs the analysis trending and interpretation of experimental data and the preparation of technical reports
- Manages the Validation group to provide technical support and direction to the Process Quality Control organization and to Manufacturing Engineering. Interfaces with Regulatory agencies in conjunction with new drug applications, facility inspections, field complaint investigations and technical interchanges to represent the company position with respect to validation and quality control issues
- Ensures efficient use of resources in order to achieve department quality and operation plan objectives. Evaluates proposed changes to products and manufacturing processes to determine validation or re-validation requirements and defines qualification strategy
- Reviews and approves validation and test protocols for adequacy and completeness. Approves and authorizes product and manufacturing process changes based on review of information, test data and reports
- Reviews and/or recommends actions with respect to the investigation of manufacturing deviations and the disposition of nonconforming product. Responsible to hire, develop, promote and discipline Validations personnel
- Knowledge of current Good Manufacturing Practices, Validation Systems, Procedures, and best practices, and overall Federal Regulatory requirements and guidelines
- Expertise in manufacturing Quality Control, Validation/Quality Engineering and industrial statistics
- Managerial/supervisory experience. Must have excellent interpersonal and communication skills and be able to effectively work with a wide variety of disciplines and all levels of management
- Must have experience in effective project management and proven leadership skills
- Requires a minimum B.S. Degree in a scientific, technical or engineering field and 5 years experience in validation of a pharmaceutical facility
- Minimum 1-2 years of Management experience
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Validation Project Manager Resume Examples & Samples
- Validation Project Manager will interface with our clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment
- This role may also support the development and execution of validation scope such as FATs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle documents
- The Validation Project Manager will be responsible for developing project scope statements, estimates and proposals
- This role may also 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 5 years’ experience with increasing responsibility in project management of life sciences, biotech or other FDA regulated validation projects
- 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
- Understanding of Quality by Design concepts and integration of Design, Build and Validation
- Experience in Business and Client Development
- Project Management experience in managing scope, cost, schedule, quality and risk is required
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Validation Engineering Manager Resume Examples & Samples
- Lead the validation team to confirm correct functionality of ASICs, FPGAs, system-level assemblies and test boards
- Develop the capabilities and expertise of the Validation Group
- Provide technical direction, training, career development and performance assessments for Validation Group members
- Formulate, propose, gain consensus and implement long range validation strategy
- Work closely with design engineers and project managers to identify validation requirements for each project
- Generate plans that address all project validation requirements and generate measurable metrics
- Engage with the design teams early in the cycle to fully comprehend design scope and requirements
- Identify the required HW/SW tools, debuggers, training and systems required by the validation team members to perform their duties
- Create project schedules for validation tasks and drive alignment back into the overall program schedule
- Provide Validation Group status with respect to deliverables, issues and schedule
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Validation Engineering Manager Resume Examples & Samples
- Develop strategic and tactical plans for addressing validation test requirements for New Product Launch
- Ensures the effective use of materials, equipment, technology, and personnel in producing quality products
- Develop Validation Strategies based on cost and quality goals
- Prepare Validation Test equipment quotations based on agreed test strategies and specifications, and recommend method of sourcing of equipment – in-house design & build, or contracted out
- Plan and coordinate global BU validation workloads by utilization of cost-effective resources globally
- Supervise and coordinate the activities of validation personnel to ensure projects are completed on time, on budget, and as specified
- Plan and define continuing education requirements in anticipation of future technologies
- Develop and support the validation team to ensure we maintain a technical competitive advantage (state of art equipment, test methods and test processes for new technologies and products)
- Plan CAPEX for future validation (new technologies) and fulfillment of customer specific requirements for testing
- Interface with internal and external customers and vendors to meet validation demand
- Coordinating and planning of testing at external laboratories including input for quotation process
- Coordinate the analysis of testing failures; ensure cooperation and involvement of all R&D experts
- Development of validation planning and test monitoring tools to provide actual status of validation testing to project teams
- Adheres to quality and safety systems or maintenance of quality and safety standards
- Bachelor’s Degree in Engineering, Masters degree preferred
- 5 years management and or project lead experience
- 8-10 years of related test and automotive validation or technical Experience
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Manager Product Expert Validation Product & Process Resume Examples & Samples
- Engineer in chemistry, biochemistry, or agronomy, Pharmacist
- At least 7 years’ experience in fermentation processing or vaccine production including knowledge of the scale up principles, quality control tests and in new production technologies
- Knowledgeable in fermentation, extraction and purification of antigens
- Quality control knowledge and in-depth understanding of process parameter, process evaluation and validation in a GMP environment
- Fluent in English and project management skills
- Scientific background and investigation skills
- Knowledgeable in change control management including implementation and execution
- Expertise in pharmaceutical aseptic production or expertise in validation or QA
- Knowledge in Specific Validation strategies (i.e. aseptic validation, computer-related system validation, RA…) and in associated process or technical topic
- Knowledge of International standards (CFR and Eudralex), GMP and Regulatory
- Experience in a complex / matrix organization
- Leading/Managing change - Designing and implementing change projects to improve business performance. Guiding a team through a period of change providing support and direction
- Provide scientifically sounded product impact assessment in complex deviation
- Manage product & process control monitoring and trending
- Manage product characterization
- Drive continuous improvement project
- Address regulatory technical request
- Provide expertise and coaching to production team
- Address product complaint investigation
- Lead product & process task forces
- Assure Product consistency and annual product review
- Develop capability & talent
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Senior Manager, Computer System Validation Resume Examples & Samples
- Develop CSV Master Plan for Vacaville Operations including anticipation of new requirements, maintaining validation status of current systems, and developing approaches and plans for new systems
- Direct the computer system validation of automation system related projects from internal staff and contractors
- Maintains staff by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, work environment; developing personal growth opportunities
- Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, developing, coordinating, and enforcing systems, policies, procedures, and productivity standards
- Develop qualification project plans, deployment plans and test plans
- Develop computer system validation test documentation
- Lead risk assessments to determine testing strategies and scope for automation related projects and changes
- Work with internal and external customers to identify and implement improvements within the Technology department related to system development lifecycle (SDLC) and change management business processes
- Develop Good Automated Manufacturing Practice (GAMP) based SDLC related deliverables such as user requirements specifications (URSs) and requirements traceability matrices (RTMs)
- Provide site stakeholder feedback to drive improvements to global initiatives, including the Pharmaceutical Quality System, the Engineering Manual and Quality Risk Management program
- Represent AESS in audits, investigations and discrepancy resolution
- Provides cross-functional participation to work closely with Manufacturing, Manufacturing Sciences, Engineering, Quality and other interdepartmental staff to meet department and company goals
- Fosters and champions a positive safety culture
- Champions self-initiated or assigned projects within the context of company objectives, and justify goals to management
- Participates on cross-functional teams dedicated to process improvement, efficiency and optimization
- Participates on cross-functional teams aimed at defining best practices and improving process performance
- Presents ideas, project goals and results within AESS and to Technology management
- Foster teamwork and drive project/process improvements
- Communicates proactively with stakeholders and management regarding progress, issues, and plans for resolution
- Expected to participate in cross-functional projects or teams in support of mission
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Manager, Actuarial Validation Unit Resume Examples & Samples
- Support and mentor Actuarial Validation Unit (AVU) team members in designing, coding and testing software for product calculation test automation; develop test strategies and lead team through each plan
- Perform automated QA and testing tasks for complex life, health and accumulation product implementations across multiple business areas; identify conditions and scenarios, determine expected results and script outcomes, and document results
- Collaborate with business and development teams to determine testing and test automation requirements; coordinate testing with other areas
- Create software test automation frameworks and tools that improve and optimize calculation testing efficiency
- Perform review of test output, and root cause analysis for discrepancies during testing; report defects and track resolutions
- Develop actuarial assumptions to use in pricing, reserving or actuarial modeling in support of business assumptions; perform actuarial analysis to develop valuation approach or risk management strategies
- Participate in backlog management, stand-up meetings, planning meetings, and post project meetings
- Serve as a liaison to other teams to help them implement calculation test automation and QA strategies
- Help define, implement and maintain quality assurance methodologies and processes in line with the larger Transamerica Quality Assurance organization
- Keep abreast of developments and trends in Agile, DevOps, Lean, test automation and software programming practices
- Guide teams in agile practices and development of team epics, user stories, acceptance criteria and tasks
- Participate in Transamerica/Aegon software and actuarial Communities of Practice and other professional development associations or activities
- Bachelor’s degree in Actuarial Science, Math or technically related field, or equivalent education/experience
- Five years of experience in the financial services industry, including detailed knowledge of products and/or systems for new business and inforce
- Expertise in one or more product lines and a high level understanding of additional product lines, which include life insurance, annuity products, retirement plans, health insurance, casualty, insurance and group/employer sponsored insurance products
- In-depth understanding of systems that support one product line and impact multiple functional areas, and working knowledge of systems that support additional product lines
- Experience in agile testing, project management, and agile software development
- Interpersonal and collaboration skills
- Eight years of related work experience
- Extensive experience with actuarial testing methodologies
- Knowledge of test driven development approaches (e.g. TDD, BBD, ATDD)
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Manager, Validation Engineering Resume Examples & Samples
- Lead a group of Validation Engineers for a group of products and contribute individually on key projects
- Demonstrated expertise in product development from conception through production in the validation of product performance, reliability, claims, and safety
- Develop product claims testing plan to validate planned claims, review results, and provide statistical summary including confidence of claim(s) desired
- Represent the function to business and functional leadership peers
- Lead product qualification test plan development, interpret test results, and work with cross functional engineering team to determine product improvement plans
- Liaise with Marketing, Project Management, and other cross-functional team members to achieve business objectives for product objectives, cost, and schedule
- Confirm product goals are achieved and release product to production
- Mentor and coach Validation Engineers assigned to succeed in a cross-functional team within a high performance organization
- Establish and execute growth plans for Validation Engineers
- B.S. or better degree in Engineering – Electrical, Mechanical, or other relevant degree
- 10+ years experience validating consumer appliance product performance
- 1-3 years management experience for two or more exempt employees
- Six Sigma Green Belt or greater
- Demonstrated organizational skills to manage multiple projects/initiatives
- Experience working with cross functional management peers
- Demonstrated proficiency in all Microsoft Office applications
- Minitab or equivalent statistical software for DoE, ANOVA, reliability, or capability analysis
- M.S. in Engineering or Business
- Demonstrated experience of influence leadership with cross functional management peers
- Demonstrated experience building functional strategy/objectives and track record of impactful execution
- Basic experience with plastics injection molding, metal stamping, and/or simple PCBs
- ASQC, CRE Reliability, or PE certifications
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Manager, System Validation Resume Examples & Samples
- Lead validation team in developing, managing, and maintaining full SDLC validation deliverables for Medpace’s regulated computer systems, including validation & test plans, User Requirement & Functional Specifications Functional & User Acceptance testing, Trace Matrices, and Validation Summary Reports
- Lead validation team to implement tools and procedures to facilitate test and document management and automate traceability
- Ensure compliance of Medpace computer systems with regulatory requirements
- Ensure compliance of system validation SOPs with regulatory requirements
- Ensure consistency of systems validation SOPs with best practices of industry
- Ensure complete and accurate documentation of Medpace computer systems; and
- Participate in Sponsor audits
- 7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry
- Excellent analytical, written, and oral communication skills
- Previous supervisory experience is preferred; and
- Experience in the regulated healthcare industry is a plus!
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Manager, Computer Systems Validation, GBT Resume Examples & Samples
- Manage a Global team of Validation Project Leads
- Enforce Covance standard testing methodologies, procedures, and practices as they relate to systems validation
- Identify and implement a common set of tools for conducting and executing computer systems validation (SDLC) that will reduce the total cost of compliance, while protecting the assets of the company
- Recommend proper controls for the Company's computer systems to ensure the reliability of applications and infrastructure, as well as the integrity of data and safety of subjects
- Provide direction to assure that Business applications and infrastructure components possess the necessary level of testing, and required documentation to comply with applicable GXP regulations and customer requirements/expectations
- Deliver technology, standards, and processes in accordance with department objectives and goals
- Prepare validation models and test strategies for Business Technology initiatives, and present to project teams
- Liaise with the GBT group and IT Compliance function to develop and implement a continuous improvement model of the Company’s validation methodology and SDLC
- Lead team by providing clear articulation of direction and expectations
- Educate and trains BU staff, business technology associates, Global AAs and Project Leads as to the Company’s validation methodology, and their respective responsibilities
- 8+ years’ experience in a FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)
