Senior Validation Engineer | Columbus, OH | Onsite
Stellent IT LLC
Title: Senior Validation Engineer
Location: Columbus, OH | Onsite
Duration: 6-12+ Months
Senior Validation Engineer Responsibilities:
- Lead/Support a Veeva 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
Job Requirements:
- 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
Best regards,
Lavesh Kumar
| Sr. Technical Recruiter
STELLENT IT A Nationally Recognized Minority
Certified Enterprise
Phone: View phone number on us.fitly.work
Email: View email address on us.fitly.work
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Vacancy posted 3 days ago
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