Validation Specialist Resume Samples

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C Bailey

Constantin

Bailey

994 Erdman Prairie

Phoenix

+1 (555) 702 8898

994 Erdman Prairie

Phoenix

Phone

p +1 (555) 702 8898

Experience Experience

Philadelphia, PA

Computer System Validation Specialist

Philadelphia, PA

Torphy-Rohan

Philadelphia, PA

Computer System Validation Specialist

Assist in the development of training material for qualification activities
Performs special projects as directed by management
Provides technical assistance and training for personnel
Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs
Generate a CSV validation plan detailing the scope of work and intent
Provides statistical support for Quality Systems monitoring and review
Work with equipment/system owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures

Philadelphia, PA

Qualification & Validation Specialist

Philadelphia, PA

Watsica, Boyle and Dickinson

Philadelphia, PA

Qualification & Validation Specialist

Define and execute improvement projects and initiatives
Investigate deviations and execute CAPAs
Perform initial & periodical Cleaning validation for all GMP equipment at site (production & QC lab)
Ensure that all activities are performed according to the schedule
Performed routine Calibration & Qualification & Validation activities
Perform initial & periodical disinfectant validation
Perform initial & periodical qualification: CIP, washer, vessel, ultrasonic bath, trolley…

present

Dallas, TX

Corporate Actions Validation Specialist Associate Shared Services & Banking Operations

Dallas, TX

Hodkiewicz-Hintz

present

Dallas, TX

Corporate Actions Validation Specialist Associate Shared Services & Banking Operations

present

Interface with external corporate action data providers
Monitor and fully understand complete flow of vendor data
Master Fidelity’s intricate announcement validation system, ActionSource
Add new announcements and update with comprehensive terms as necessary
Reconcile internal data with external Custodian information
Review and understand announcement details requiring validation
Extensive interaction with various departments including international Position Services groups, Prime Brokerage and Controllers via outbound and inbound emails and the telephone

Education Education

Bachelor’s Degree in Computer Sciences

Bowling Green State University

Bachelor’s Degree in Computer Sciences

Skills Skills

Code of Federal Regulations and CGMP’s relating to the field of Computer System Validation
Capable of demonstrating strategic thinking by maintaining a focus on project goals and global targets while meeting local and near term objectives to secure their implementation
Demonstrate an understanding of automation, PLC, Software and Hardware engineering
Experience with Electronic Data Management Systems
Ability to establish clear priorities quickly
Ability to work effectively under pressure, handle multiple projects and meet deadlines
Ability to lead Computer System Validation projects for the site
Ability to write technical documents (like Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc)
PC literate, Microsoft Office and spreadsheet software
Mathematical and reasoning ability

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Income Validation Specialist Team Lead Resume Examples & Samples

Duties will include but is not limited to, interviewing, selecting and training employees, set and adjust rates of pay/hours of work, directing work/assignments, maintain production records, appraising employee performance, recommending increase/promotions or other changes in status, handling employee complaints/grievances and disciplining employees etc as needed
Monitor pipeline queue, reassign loans based on volume and UW capacity
Maintain the work schedule for the department, limiting if necessary number of pre approved absences
Maintain daily log of work completed by the department
Work with 2nd review team to resolve income and rationale discrepancies between the original IVS and 2nd reviewer
Liaison between IVS department and Asset Management
Work with IVS Manager to develop departmental policies and procedures
Special projects as required by IVS Manager, Assistance VP of IVS and First VP of IVS
Mentor team as needed to ensure that we are working consistently across the board
Responsible for managing all Income Validation Specialist (IVS) which will include but not limited to hiring, firing, coaching, bonus determination, performance reviews
Extensive knowledge of the guideline for Income Calculations and program requirements, possess a minimum of 2-5 years Underwriting Experience
Proven experience in Income Calculations and some Supervisory experience
Must be willing to travel between Pompano and Miami office on an as needed basis. Strong Excel and Word/Office experience
Strong demonstrated knowledge of tax returns (personal and corporate)
Ability to adapt to multiple guidelines for different modification programs
Maintain a strong working knowledge of HAMP and FHLMC and Investor Guidelines
Ability to manage and perform multiple tasks accurately in a fast-paced and challenging environment
Ability to be flexible with time constraints based on departmental needs
Must be organized with excellent verbal and written communication skills
Ability to work under pressure, with quick results
Ability to meet with Senior Management to discuss current status of department and other issues as they arise pertaining to the underwriting group
Bachelor's degree in Business, Accounting, Finance or related field or equivalent work experience
Strong computer skills with intermediate proficiency with MS Word/Office and Excel

Computer Validation Specialist Resume Examples & Samples

5+ years' experience with computer validation
Experience in validating computer systems in the pharmaceutical industry
Demonstrated experience in successfully managing complex validation projects
Demonstrate respect for team members and their opinions
Familiarity with Laboratory Systems and Manufacturing Control Systems
Experience validation ERP or other Business Applications

Senior Computer Validation Specialist Resume Examples & Samples

Bachelor’s degree in Computer Sciences, Engineering, or related discipline
2+ years of experience in the biopharmaceutical industry
Working knowledge of various laboratory instrumentation systems and techniques
Working knowledge of good documentation practices, cGMP, regulatory requirements for computerized analytical systems validation (i.e. 21 CFR part 11) and disaster recovery

Corporate Actions Validation Specialist Associate Shared Services & Banking Operations Resume Examples & Samples

Monitor and fully understand complete flow of vendor data
Review and understand announcement details requiring validation
Research, resolve conflicts, locate missing information within specified timeframes utilizing external and internal data sources
Add new announcements and update with comprehensive terms as necessary
Reconcile internal data with external Custodian information
Master Fidelity’s intricate announcement validation system, ActionSource
Extensive interaction with various departments including international Position Services groups, Prime Brokerage and Controllers via outbound and inbound emails and the telephone
Field high volume of diverse inquiries from various consumers (business units) of CAVS data
Interface with external corporate action data providers
Learns quickly and displays adaptability
Shows initiative, is self-motivated and also works well with a team
Proficient written and verbal communications skills
Write technical documents, business specs, test plans and scripts

Engineering Applications Method & Validation Specialist Resume Examples & Samples

Support of the corporate CATIA V5/V6 and Designer Central/VPM portion of ENOVIA V6
Development and support of "Winforms" Windows applications (around CATIA and other engineering tools) using C# and the .NET framework
Keep abreast of current and upcoming needs to inform software purchases and infrastructure development

Senior Validation Specialist / Manager Resume Examples & Samples

Work closely with commercial team and biopharmaceutical end users, to understand and identify the important areas of validation required to serve the market needs
Work closely with global regulatory and validation experts, to translate the knowledge and application into China market, as well as feedback China needs for central prioritization
Proactively engage with biopharmaceutical customers to offer GE validation services and capability, to help their clinical pathways
Shortlist and prioritize the validation services (extractables/leachables, filtration validation, etc.) to be set up based on the market need to better support GE LS growth. Identify the right testing suppliers (both internal and external) and manage all through to achieve the best result for both GE and customers
Set up the validation testing protocols, project management for the actual testing processes, through to deliver the approved report to biopharm. Customers
Initial responsible for developing and improving extractables/leachables documentation and testing; Write and revise protocols, procedures, reports and other documentation as necessary to support the customer; Identify critical process parameters and conducting experimental analyses; Utilize scientific principles and experience to independently execute and optimize experiments in the process of validation; Work with internal associates and external experts to manage the challenges including unexpected experimental difficulties, technical hurdles, trouble shooting and conflicts within test project; Cooperate and communicate with project coordinator to ensure project progress
Deliver validation trainings to customers and speeches during key events and conferences
Drive for opportunities to interact with regulatory agency (CFDA) and biopharm. Customers to understand the latest guidelines/policies for bioprocessing and single-use regulations
Establish the validation services capability for GE life sciences in China. Shape GE as the leading validation services provider in the biopharm. Market
Shortlist and prioritize the validation services (extractables/leachables, filtration validation, etc.) to be set up based on the market need to better support GE LS growth
Provide expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing project
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations
Responsible for developing and improving extractable documentation and testing; Write and revise protocols, procedures, reports and other documentation as necessary to support the customer; Identify critical process parameters and conducting experimental analyses; Utilize scientific principles and experience to independently execute and optimize experiments in the process of validation; Work with internal associates and external experts to manage the challenges including unexpected experimental difficulties, technical hurdles, trouble shooting and conflicts within test project; Cooperate and communicate with project coordinator to ensure project progress
Problem solving ability and excellent oral and written English communications skills
Minimum Master Degree in Science, Engineering or a relevant Quality discipline
Minimum 5 years experience in a similar role
Proven and progressive previous experience in validation/services/QA/RA/R&D/Process development for biopharmaceutical applications
Extensive polymer chemistry and analysis/characterization knowledge and experiences for medical device or pharmaceutical/biopharmaceutical
Knowledge of biopharmaceutical processing, such as upstream, filtration, UF/DF, Chromatography, formulation, single-use technology, and the relevant validation
Knowledge of cGMP’s and other worldwide regulatory requirements. BPSA, PDA, BPOG, GMP, USP, FDA, ICH, EP, JP, ISO, REACH, ISPE and ASTM Standard

Senior Computer System Validation Specialist Resume Examples & Samples

Directly manage assigned projects to satisfy specific project/client needs
Promote client-based and solutions approach
Generation / execution of System Impact and Critical Aspect Assessment Impact
Coordinate and interface with project managers, as well as engineering and quality assurance groups to ensure successful project execution
Lead cross-functional project teams in the development of validation deliverables
Review and approve validation project documentation
Develop validation deliverables including master plans, protocols and summary reports, as required
Bachelors degree in computer science, computer engineering, life science, or any other pertinent degree
Minimum of 10 years of experience in a highly regulated environment: pharmaceutical, biotechnology or related industry
In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
Familiar with off-the-shelf, configurable, and custom-developed applications
In-depth knowledge of validation deliverables associated with each step of the computer system life cycle
Demonstrated experience working Delta V/OSI
Prefer experience working with Rockwell PLCs and HMIs, Siemens S7 PLCs, WinCC SCADA, Rockwell FactoryTalk HMI, Building Management System, IFIX, Experience in process automation an asset
Familiar with computer system infrastructure, including: networks, servers, related hardware and supporting software, and peripheral hardware
Possess strong analytical and decision-making skills
Position demands an individual who is willing to travel

Junior Technologist / Validation Specialist Resume Examples & Samples

Minimum 3 years of experience in supervision or support production processes
Expertise in the field of manufacturing or packaging process
Advanced knowledge of Office (Excel) and ERP systems eg. SAP
English is a must - working with the technical documentation

Computer System Validation Specialist Resume Examples & Samples

Applies and enhances existing computer system validation programs for the validation of new production and laboratory computer systems, including major capital projects and computer systems
Maintains and enhances computer system validation program for existing computer systems
Drafts, reviews, executes and approves protocols and reports related to computer validation. This includes deviation reporting during execution
Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management
Assists validation contractors as required
Ensures that the site Validation Master Plan remains current and aligned with corporate policies as it pertains to computer system valiation
Provides statistical support for Quality Systems monitoring and review
Reviews and approves changes to computer systems through the change control program to assess impact on validated systems
Assists in customer / regulatory audits and responding to audit observations and corrective actions as it pertains to computer system validation
Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes
Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs
Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements
Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
Performs special projects as directed by management
4+ years applicable work experience in cGMP related industry
Proven track record in validation and qualification of complex computer systems
Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards

Manufacturing Equipment Validation Specialist Resume Examples & Samples

Perform criticality analysis for initial or on-going validation/qualification based on the Merial Global Quality standards and regulatory requirements
Develop and document the process and project Validation Master Plans (VMPs)
Plan and structure validation activities for facilities and equipment in coordination with engineering project management and/ or manufacturing management
Attend and monitor execution of factory acceptance testing at supplier’s site when necessary
Ensure that the validation activities identified in the VMP are implemented and documented through protocols for design, installation, operational, software and performance qualifications
Develop a project validation summary report at the end of the project based on Merial validation reporting template requirements
Hands-on Process Validation Master Plan support, develop validation protocols, review and audit protocols, update the VMP’s, in collaboration with manufacturing teams
Perform and assist with the execution of validation activities
Responsible for hands-on training and development of manufacturing capability in execution of validation
As Lead role, maintain and report environmental monitoring results to QA and site senior management and also to facility owners. Develop and report metrics as needed
As Lead role, ensure all Select manufacturing sites water systems are compliant with Merial Global Quality standards
Adhere to all Merial HSE guidelines and regulations
In addition to the above, other assigned duties & projects deemed appropriate within the position scope
Strong organizational, time management, and project management skills, with exceptional attention to detail
Works effectively in a team environment, with excellent reasoning and negotiating skills
Results oriented and ability to meet firm deadlines while working in a complex and variable environment
Requires knowledge of the current GMPs and USDA requirements
Requires critical and analytical thinking skills along with ability to make some independent decisions
Requires frequent walking, stooping, bending, twisting, turning, and standing for extended periods of time and some lifting, pulling or pushing up to 50 lbs
Must be able to stand for extended periods of time and work in a sterile production environment
Manual dexterity and visual acuity are important
Must be able to wear appropriate Personal Protective Equipment (PPE)
Requires critical and analytical thinking skills
Proficient with Microsoft Office software and other database software

Validation Specialist Resume Examples & Samples

Identifying and defining issues, developing criteria, reviewing and analyzing contracts and Health Plan reimbursement regulations
Updating and developing new and current audit reports, developing and running custom queries
Working with a variety of claims including Medicare, Facility, In-patient, and Out-patient
Minimum 1 year experience in medical insurance claims billing, or analysis required

Computer System Validation Specialist Resume Examples & Samples

Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment and systems according to the GAMP5 Validation Life Cycle. Documents includes like Computer System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review
Generate validation protocols in line with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations
Generate a CSV validation plan detailing the scope of work and intent
Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements
Ensure all work is in line with the site Master Validation Plan, regulations, procedures and practices
Ensure that the site Validation Master Plan remains current and aligned with corporate policies
Lead and conduct validation activities in compliance with US and EU regulations (regulations for all countries where have business) procedures and EHS requirements
Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations
Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan
Prepare validation summary reports for executed protocols
Liaise with manufacturing and laboratory groups in execution of the Validation program
Communicate Computer System Validation approaches and requirements during audits
Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments
Anticipate and assess/prevent technical problems from impacting product and processes
Generate and maintain Computer System Validation procedures in line with corporate guidelines procedures, CGMP, Corporate policies/standards and ISPE GAMP guideline
Work with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures
Track and resolve deviations/exceptions during qualification activities
Prioritize qualification activities in line with the project schedules and timelines
Co-ordinate validation/qualification activities with key stakeholders
Assist in the development of training material for qualification activities
Serve as the SME for CSV presentations and maintain knowledge and information in the CSV area of expertise
Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication working as a strategic partner with all other departments within the company
Achieve results through the development/optimization of people, processes and systems – requirement to harness creativity of multi-disciplined teams
Manage Validation contractors to complete on-site validation if required
Lead and participate in cross functional teams as defined by the site management team
Facilitate an environment of continuous improvement
Comply with Health, Safety, and Environmental responsibilities for the position
Prefer Five (5) to seven (7) years in a CGMP-related industry with at least three (3) to four (4) years of Computer System Validation experience working with cGMP pharmaceutical/nutraceutical regulated industries and 21 CFR Part 11 compliance (world CSV regulations). Other preferred validation experience in the following areas will be considered plus: Equipment/Instrument Qualification, Cleaning Validation, and Process Validation
Code of Federal Regulations and CGMP’s relating to the field of Computer System Validation
In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines
Experience with the following applications/systems is preferred: Wonderware/OSI-PI (or other similar systems), WinCC, Allen Bradley PLCs/equipment (RSView, PanelView, RSLogix), ladder logic programming
Capable of demonstrating strategic thinking by maintaining a focus on project goals and global targets while meeting local and near term objectives to secure their implementation
Demonstrate an understanding of automation, PLC, Software and Hardware engineering
Experience with Electronic Data Management Systems
Ability to establish clear priorities quickly
Ability to work effectively under pressure, handle multiple projects and meet deadlines
Strong verbal and written communication skills, good decision making skills and time management skills is a must; ability to interface with all levels of the organization
Ability to lead Computer System Validation projects for the site
Ability to write technical documents (like Validation plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report etc)
PC literate, Microsoft Office and spreadsheet software

Order Validation Specialist Resume Examples & Samples

Review, Validate and Approve State and Local Govt, Canada & Commercial Business Purchase Order based orders
Manage and Input ERA requests (equipment returns)
Ensure new customer set up requests follow the Corporate and Credit Policy and are Tax Compliant
Drive comprehensive application of global and regional Credit, Tax and Finance policy for all orders
Adapt to a fast paced business with a focus on first in, first out cycle time on orders, but still maintain the ability re-prioritize if business need dictates
Monthly close activities that result in heavier workloads
Management of customer expectations, both internal and external
Business fluent Polish, English
Additional languages desired and a plus (French Canadian)
Excellent knowledge about MS office
Excellent time management
Excellent communication skills, self motivated and able to work under pressure

Computer System Validation Specialist Resume Examples & Samples

Responsible for instrument validations within Global I&I in accordance with current Covance guidelines
Partner with Global Business Technology (GBT) Computer Systems Validation (CSV)team to ensure current guidelines are met in system validations
Coordinate the evaluation and recommendations of new instrumentation across Global I&I to ensure alignment of technologies where possible
Point of Contact with relevant companies to obtain details on goods/equipment as required
Responsible for introduction, implementation and continuing compliance of any instrumentation when required
Assist in the introduction of new techniques, methodologies and relevant procedures in collaboration with the Senior Technical Specialists where required
Ensure the Systems Inventory is up to date at all times
System Life Cycle Documentation
2 years related experience with a Bachelor's Degree
3 to 5 years related experience with no degree

Equipment Calibration & Validation Specialist Resume Examples & Samples

Education: Bachelor of Science degree in Chemistry and or in Biological Sciences or equivalent in experience or training
Experience: Minimum of 5 years previous laboratory equipment control experience or laboratory experience with strong understanding of laboratory equipment calibration/PM and qualification’s regulatory requirements
Good understanding of the laboratory quality control processes
Comfortable with sophisticated LIMS IT System
ASQ Certification as a Calibration technician is an asset
Ability to troubleshoot or diagnose equipment problems as needed to minimize down time alternatively ask Subject Matter Expert
Candidates must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook)
Ability to work well with others & independently
Proven time management skills and a strong attention to detail
Ability to interpret and analyze data
Must be highly organized and able to work effectively and efficiently in a demanding environment with frequently changing priorities
Extended hours and shift work may be required from time to time
Ensures full compliance with the company’s Health & Safety, Code of Integrity, and Professional Conduct policies
Appropriate attitude, constant vigilance, attention to detail and following Training SOP for training and training records

Computer Systems Validation Specialist Resume Examples & Samples

Manage the full lifecycle of validation projects including but not limited to delivering on time and to specification ensuring the delivery of a quality validation project at all times
Write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications
Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices
Maintain appropriate validation documentation and files including the Master Validation Plan (MVP). Archive all validation documentation
Write or assist in the writing of SOPs for the Validation Department
In collaboration with the technical/lab operations department plan installation, regular maintenance and repair of computerized systems and ensuring appropriate documentation
Coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc
Train and coach staff in relation to validation projects as required
Manage cross functional teams involved in the validation project deliverables (e.g. Project Team, IT, Departmental Managers, vendors, etc)
Provide project updates and input into established project documentation
Effectively communicate project expectations to team members and stakeholders in a timely and clear manner
Assist other departments in response to their validation requirements as required
Report any non- compliances of Quality Management System with respect to validation to the Senior Management
Identify plan and schedule project timelines and milestones using appropriate tools
Develop and implement solutions to validation issues
Present validation systems program during internal and external audits
Education: Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline
Experience: 5-7 years related experience in Computer System Validation. Prior experience working in a GxP laboratory is preferred
Certification/Licensure:Test or validation certification desired
Other: Comprehensive knowledge of regulatory requirements, including GxPs, Part 11, as they pertain to computerized systems, is preferred. Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment

Product Validation Specialist Resume Examples & Samples

Define, document, and execute functional tests for embedded software including Graphical User Interfaces based on product requirements and usage scenarios
Monitor and report on automated testing activities
Provide accurate test results through a problem tracking application
Define and execute test regression plans for maintenance releases/patches/ECOs
Provide status reports as required to project and line management
Must be able to prioritize and manage multiple tasks, define problems, and working with larger team develop a means or method to resolve them
Other Duties as assigned
Coursework in Computer Science or related Technical Field
Experience with any of the following: Windows, OSX, Linux
Experience with iOS and/or Android
Basic understanding of home networking such as; TCP/IP, DHCP, DNS, Home routers
Working knowledge of home theater including HDMI, Surround Sound, TVs, AVR, Etc
Excellent Verbal and Written communication skills
Familiarity with any of the following: Home Alarm Systems, IP Cameras (including ONVIF), DVR/NVR, Lighting/Home Wiring is a plus
Reasonable Accommodations may be made to allow individuals to perform the essential functions of the job

Process Validation Specialist Resume Examples & Samples

Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West Validation program
Provide guidance to system/process stakeholders as to content and format of Validation lifecycle documentation and deliverables
Facilitate Risk Management and impact assessment activities within the Validation lifecycle related activities
Support Engineering and Operations groups during process development and process qualification Validation lifecycle stages
Facilitate required training to support qualification activities
Provide guidance during protocol non-conformance process, including reporting, investigations and approval of resolutions
Keep current with all Industry standard practices and FDA requirements for validation

Computer Validation Specialist Resume Examples & Samples

Education: Bachelors degree in Science, IT, Engineering or equivalent experience
Experience: Must have over 5 years laboratory instrument and laboratory software applications experience
Experience should include the pharmaceutical laboratory laboratory systems such as Empower and/or Open Lab CDS systems, Agilent, Waters, ThermoFischer with typical instrumentation such as GC, HPLC, ICP-MS, MS/MS, Spectrophotometers, FTIRs
LIMS Systems administration and configuration
Experience in instrument configuration and qualifications in a GxP / biological laboratory environment
Working knowledge of GxP regulations and regulatory standards for computer systems validations

Computer System Validation Specialist Resume Examples & Samples

Implement Innomar’s computer system validation (CSV) strategy and lead validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with PIC/S Annex 11 and US-21CFR part 11 requirements is established and maintained at all times
Review and/or assist in developing validation strategies and associated documentation against the requirements of Innomar’s CSV Policy and Procedures, as well as the Validation Master Plan (VMP) to ensure that compliance and business needs are achieved
Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include: Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ/OQ/PQ Testing Protocols, Test Cases, Validation Summary Report, Change control, SOPs, etc
Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements
Effectively manage all assigned computer validation projects, enhancements, and requests for change (RFCs), including the review of high level estimates (HLEs) from IT/PM to ensure QA timelines provided/forecasted are consistent with the expected project completion date. Complete assigned projects and tasks within agreed deadlines
Design/create and execute test cases (e.g., functional tests, integration tests, challenge tests, regression tests, etc.) and setup data for tests scripts that are appropriate to the risks and purpose of the applications and enhancements
Provide guidance and/or support to other members of the validation team (including operational business units, IT and 3rd party vendors) in the development of validation deliverables, such as User Requirements Specifications (URS), 21CFR11/Annex 11 assessments, Functional Requirements Specification (FRS), Design Specifications, etc
As necessary and where applicable for validated systems, obtain and review Unit Test documentation from the IT development team/vendor to ensure the codes released to the test environment have been adequately unit-tested prior to QA validation activities
Management of defects/deviations/incidents in validation projects, including
Logging all defects/deviations/incidents identified during IQ, OQ & PQ
Organizing defect/deviation/incident Triage Meetings with the required stakeholders to identify resolution – e.g., whether to fix and retest, or defer to a later release
Maintain and update defect/deviation/incident log with appropriate status prior to closure of the project for filing
Coordinate and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review
Maintain computer system validation documentation and archiving ensuring effective document retrieval when required
Coordinate with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, practices and tools. This may include formal preparation of training materials, one-on-one training, and classroom training
Provide quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements
Conduct QA audits of IT and validation processes as scheduled
Review & provide input, where required, to CSV-related Standard Operation Procedures (SOPs) and/or policies, and ensure adherence to internal SOP’s and regulatory requirements
Keep current with relevant industry and regulatory guidelines
Coordinate and provide direct oversight of third party vendors/partners for all software validation activities assigned
Flexibility to work overtime when required
Requires formal training in the field of computer sciences (e.g. IT, information security, engineering, software programming, etc.), business administration or similar vocations generally obtained through completion of a four year Bachelor’s Degree program, technical vocational training, or equivalent combination of experience and education
Requires a thorough knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11and other harmonized international guidelines (PIC/S, ICH) and GxP
Ability to communicate effectively both orally and in writing is a must
Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits)
Hands-on experience in validation of GxP systems is required
Experience in auditing of IT and validated systems are required
Excellent teamwork and interpersonal skills; leadership and relationship building skills
Excellent organizational skills; attention to detail
Ability to resolve system issues effectively and efficiently
Practical understanding of project management principles and methodologies
Experience in creation and review of Standard Operating Procedures (SOP’s) is desirable
Experience in using automated enterprise testing tools is an asset in order to support and assist company’s testing initiatives
Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO
Working knowledge of relevant technology, tools and software; knowledge of UNIX, SDLC, Desktop services, HP Test tools, or equivalent testing tools

Clinical Validation Specialist Resume Examples & Samples

Bachelor’s degree or equivalent in a field related to medical diagnostic imaging preferred
Advanced certification in PET/CT preferred
Dual certification in CT and Nuclear Medicine or CT and Radiation Therapy preferred
Understanding of FDA/MDD design validation regulatory requirements
Proficiency with data management tools (e.g. ClearQuest, DOORS, and Agile

Computer System Validation Specialist Resume Examples & Samples

This role is 100% on site
Basic coding or computer development
Script development
Pharmaceutical experience is a huge plus but not required

Data Validation Specialist Resume Examples & Samples

Minimum 2 years of experience in data acquisition, data analysis, or customer service required, preferably in a healthcare environment
Completion of junior and senior courses in pursuit of a bachelor's degree from an accredited
College or university with major coursework in mathematics, health care management, business administration, or a related field may be substituted for work experience

Computer System Validation Specialist Resume Examples & Samples

Performs and leads computer system validation projects related to authoring and executing specifications and validation documentation for equipment/systems, laboratory instruments/equipment and systems according to the Good Laboratory Practices (GLPs) and FDA 21 CFR Part 11. Documents includes like System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Business Continuity Plan, Disaster Recovery Plan, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM) and Periodic Review of Computer Systems
Ensure all work is in line with the site Validation Master Plan, regulations, procedures and practices
Maintain VMP, Vendor questionnaires as applicable
Review and execute Computer System Validation protocols to ensure compliance and adherence with applicable guidelines
Write risks assessments and applicable test scripts according to GLP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan
Liaise with various laboratory function within organization in execution of the Validation program
Communicate Computer System Validation approaches and requirements during planning/audits
Facilitate continuous improvement of WuXi’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout WuXi
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
Work with equipment/system owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures
Serve as the SME for CSV and maintain knowledge and information in the CSV area of expertise
Degree (Bachelors or Masters) in Computer/Electrical Engineering or other relevant Science Field
Prefer at least three (3) to four (4) years of Computer System Validation experience working in a regulated, GxP environment
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
Experience with the following applications/systems is preferred: Analyst, Debra, Laura, Watson LIMS, AIDA and other typical regulated lab systems

Validation Specialist Resume Examples & Samples

Performing the data mining and auditing functions of medical claims that have already been paid by our clients (United Healthcare, Cigna, and Blue Cross and Blue Shield)
You are assigned your own accounts each month to investigate and will spend the majority of your day performing research in our client’s systems to identify overpaid or incorrectly paid medical claims. For those claims that you find, we document and investigate exactly what happened and then turn the account over to someone in the collection department to perform the collections
You will not be performing any collections. You will have monthly goals that are set for you. There is a quantity goal for how many accounts you must work as well as a quality goal related to how many overpaid accounts you identify
This position does not require you to spend time on the phone, the major goal of this position is performing research
Determining which insurance plan has the primary payment responsibility and which has the secondary payment responsibility
Identify and validate potential overpayments or incorrectly paid insurance claims, and process according to established process and procedures
Investigating claims data to identify overpaid/incorrectly paid claims in order to initiate the activities needed to recover the overpayment

Senior Software Validation Specialist Resume Examples & Samples

Primary Responsibilities
Bachelors degree (BA/BS) in life sciences, informatics, information technology, computer science, or equivalent professional experience
Two years of consultancy experience in life sciences validation, field engineering, or field applications
Three years of domain-specific experience in molecular biology, proteomics, or equivalent laboratory experience
Project Management Institute Project Management Professional certification a plus
Application knowledge in the tools utilized in SCIEX instrument and analysis software
Familiarity with the Oracle RDBMS
Requires the ability to perform independently from a home/remote office and as part of a team
Demonstrate effective verbal and written communication skills to understand the customers’ requests and articulate them in document form to technical as well as non-technical team members
Demonstrate strong consultancy skills in order to manage customer expectations and maintain project scope

Validation Specialist, Analytical Instrument Resume Examples & Samples

Perform analytical computerized instrument and software validation, spreadsheet validation and validation periodic review to support a variety of the labs within QC organization
Prepare IOQ and other life cycle documents with high quality and accuracy
Write validation protocols and final reports and function as a validation SME. Conduct

Computer Validation Specialist Resume Examples & Samples

Perform analytical computerized instrument and software validation, spreadsheet validation and validation periodic review to support a variety of the labs within QC organization
Prepare IOQ and other life cycle documents with high quality and accuracy
Write validation protocols and final reports and function as a validation SME
Conduct computer and software validation, validation periodic review
Ensure validations are within compliance by following industry standards, corporate policy, and regulatory requirement
Interact with Regulatory agencies, customer, and internal auditors/inspectors as needed
Support regulatory filings with documentation as needed
Write and/or revise SOPs, and maintain all validation related documentation
Manage multiple projects with ability to trouble shoot and seek solution
Commitment to safety by following and promoting programs regarding health, safety and protection of environment
Bachelor’s Degree in Science or Engineering
4+ years’ experience in performing analytical computerized instrument and software validation
Strong understanding of cGMP, 21 CFR Part 11, global regulatory compliance
Strong understanding in data integrity
Strong technical/business writing and communication skills
Knowledge in risk assessment, gap analysis, changes control and deviation management
Strong computer skills, including Word, Excel, PowerPoint and databases
Must be able to demonstrate knowledge of validation principles, including user requirements, system specifications, IQ, OQ, and PQ
Ability and initiative to work with minimal supervision required
Strong ability to plan and prioritize complex and conflicting objectives to meet release goal
Excellent organizational skills, capable of multi-tasking and creating validation/qualification documents for multiple projects simultaneously

Software Validation Specialist Resume Examples & Samples

Works with customers to either modify existing validation scripts or create new validation scripts for SCIEX instrument software to meet specific customer needs
Provides GLP and/or GMP instrument and software validation consulting services to customers based on the established Professional Services project management methodology
Helps customers identify, troubleshoot, and debug validation failures
Writes detailed documentation describing validation failures including customer IT issues, IT configurations, interfacing requirements, etc. as needed to communicate issues/problems to team members and customer representatives to troubleshoot validation failures
Works with customer IT representatives, end users, clients and field application specialists, product representatives, and field engineers to solve validation failures
Writes proposed solutions and remedy responses based on customer requirements and business needs
Estimates effort required to modify existing or create new validation scripts based on customer requirements, configurations, workflows, etc
Provides validation documentation and training materials to customers as needed
Ensures application security is adequate and maintained
Consults with end users to identify current operating procedures and develops/updates validation scripts accordingly
Develops “best practices” for various phases of project lifecycle
Conducts custom training based on training materials developed as part of a project
Maintains project documents using the Business Operations PMO document repository
Reports task and/or project status to the project manager(s) as needed by the project manager(s)
Tracks times spent on tasks and reports this information to the project manager(s) each week
Works with third-party consultants in the development and execution of validation scripts. Tracks contractor time and progress. Reports/invoices contractor time to project manager/customer as needed
Works with Marketing and Product Management to develop and incubate new service offerings
Client personnel – gathering requirements, understanding business processes, and reviewing processes with customer
Field application specialists (FAS), field service engineers (FSE), support engineers
Professional Services IT and Networking Specialists
Professional Services management
Professional Services project managers – report time and project-related issues on a timely basis. Coordinate technical activities
Oversee technical activities of field team
Instrument and software product managers
Customers – business managers, scientists, technicians, & IT staff
Third-party consultants – communicate requirements, oversee work activities, ensure product/deliverable quality
Strong technical skills sufficient to document customer requirements and communicate solution estimates (with appropriate technical review) to clients
In-depth understanding of customer business, goals, objectives, strategies, and needs
General instrument and software validation knowledge including GLP, GxP, and FDA 21 CFR 11 guidelines
Familiarity with general networking and IT standards including LAN/WAN/SAN and TCP/IP
Familiarity with data management standards including data archival, data restoration
Familiarity with the Windows configuration
Ability to instill customer satisfaction that is recognizable and valuable to the customer
Effectively communicate pros and cons of validation alternatives to the customer and project manager
Interpret customers’ needs and identify solutions

Verification & Validation Specialist for Non Product Software Resume Examples & Samples

Support IS and business teams with developing and delivering validated tools, compliant platforms and solutions
Contribute toward the development of a customer focus and collaborative attitude with V&V team as well as with project members and stakeholders. Ensure that internal customer requirements and expectations have been accurately identified
Ensure that all project participants (project manager, business analyst, developer, business representative) are accountable for their part of the V & V activities and V & V inputs
Ensures schedules are executed on time, project costs are respected and required compliance levels are achieved
Manage risk, produce verification and validation plans, protocols, and reports; lead the execution of the plans and protocols, and manage deviations
Support supplier and internal audit initiatives related to verification & validation activities
Experience in software lifecycle management
Significant experience within or in partnership with technical, business and quality management personnel
Solution orientated attitude
Language: Fluent in English, French appreciated

Qualification & Validation Specialist Resume Examples & Samples

Perform initial & periodical Cleaning validation for all GMP equipment at site (production & QC lab)
Perform initial & periodical disinfectant validation
Perform initial & periodical qualification: CIP, washer, vessel, ultrasonic bath, trolley…
Write risk assessment and rational link to Cleaning
Performed routine Calibration & Qualification & Validation activities
Ensure that all activities are performed according to the schedule
Ensure that all activities are properly documented
Write qualification and validation protocols and reports and other documentation related to the activities
Investigate deviations and execute CAPAs
Define and execute improvement projects and initiatives
Participate in customer and authority audits
Can be involved in other process validation activities
Master degree in Biology/Bio-Engineering or equivalent
At least a first experience in the pharmaceutical/agro-food industry (GMP knowledge)
Experience in Cleaning validation / CIP / Washer / PDE
Fluent in French and English
Integrity, positive energy and mind-set, team-player
Excellent communication skills
Accountability for results and persistency
Adaptable and risk analysis thinking

Scientific Computer System Validation Specialist Resume Examples & Samples

To be responsible for, and advise on the need for, validation (including regular evaluation of validation status) and routine maintenance/calibration of laboratory equipment (and associated facility services) for Laboratory Sciences
To manage departmental spreadsheets, data capture software systems and equipment to ensure that they comply with the requisite regulations including compliance to principles of Good Laboratory Practice (GLP) where appropriate
To design, execute and report equipment/facility validations according to GLP. To act as Responsible Person for generic equipment
To author or contribute towards Standard Operating Procedures (SOPs)

Facilities & Utilities Validation Specialist Resume Examples & Samples

Responsible for the generation and execution of validation project plans, protocols and reports specifically related to facilities (eg. manufacturing unit, cell banking and warehouse) and utilities (including special gases)
Planning and managing delivery of validation projects and procedures to meet current GMP regulations and guidelines, industry best practice and company policy
Formal review of validation protocols, reports and procedures generated by Lonza staff or external vendors
Process and manage quality records including change control, deviation and CAPA
Plan all work with and report progress to the validation scheduler, line manager and internal customer to ensure validation activities are aligned

Senior Validation Specialist Resume Examples & Samples

Provide QA oversight of commissioning, qualification and validation activities to deliver Moderna’s new early phase GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods and personalized medicine capabilities
Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues
Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments
Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation
Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements
Responsible for supporting internal and external inspections as a Subject Matter Expert for Quality Assurance Validation
Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs
Oversight of contractors/consultants in performing similar tasks supporting large projects, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product
Bachelor’s degree in a scientific or health-related field required
Minimum of 5 years of Validation experience in the biotechnology or pharmaceutical industries required
Experience in IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility startup environments is a plus
Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Uses a team-oriented approach to project management and problem resolution
Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations. Ability to interact effectively with all levels of personnel within the organization
Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate
Proven ability to manage projects while meeting all deliverables and timelines
Strong knowledge of global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11
Demonstrate strong organizational skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail
Practical experience with Quality by Design is a plus

Business Validation Specialist Resume Examples & Samples

Facilitate business validation process, including, but not limited to, providing and collecting required documentation from each client manager and IC
Review client manager and IC documentation information for accuracy and completeness
Determine if IC meets client's qualification criteria as a true IC or should be submitted to PRO's Scoredesk for futher analysis, per business validation processes; determination of Waivable or Screening not required
Research status of company to confirm if in good standing
Create/build a good working relationship with on-site team/client
Provide on-going communication to CSC and/or client regarding pending screenings, escalations, etc
Facilitate escalations to CSC and/or client for contract changes, insurance changes, etc. (if applicable)
Prepare final IC agreement, Consultant Consolidation Services Agreement (CCSA), or amendments for execution processes (if applicable - client specific)
Collect Certificates of Insurance from IC with active projects and maintain insurance documents for active CCSA's, ensuring up-to-date certificates are on file (if applicable)
Must achieve a score of 80 or above for all internal audits
Extensive Data Entry and Maintenance of WAND Database
Must meet client specific requirements with respect to business validation deadlines or contractual deadlines
Draft and maintain client specific and departmental Standard Operating Procedures (SOPs)
Create and maintain IC files per departmental procedures
Update departmental reports, including the Weekly Activity Report, client specific reports, and ad hoc reports
Provide on-going support to the department/company, including, but not limited to, leading special projects, reporting, maintaining client specific templates/applications, SOP updates, etc
Provide back-up support for any other client account within department as needed