Senior Validation Engineer
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-08-30
Listing for:
Creative Solutions Services, LLC
Full Time
position Listed on 2026-08-30
Job specializations:
-
Quality Assurance - QA/QC
IT QA Tester / Automation, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Roles & Responsibilities :
- Lead/Support aVeeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout
- Develop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs
- Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needs
- Support Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolution
- Apply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintained
- Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation
- Participate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementation
- Provide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolution
- Ensure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles
- Support inspection and audit readiness by ensuring complete, accurate, and traceable validation documentation.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
- 5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments
- Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
- Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrity
- Experience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reports
- Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principles
- Strong project management, organizational, communication, and problem-solving skills
Position Requirements
10+ Years
work experience
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