CSV/CQV Validation Specialist
Intellectt INC
CSV/CQV Validation Specialist
Location: Bend, Oregon
Work Arrangement: Onsite
Employment Type: Contract
Payrate: $50 - $60/hr on W2
Duration: 6 Months
Industry: Biopharmaceutical / Pharmaceutical Manufacturing
Experience: 3 5+ years
About the Role
We are seeking a CSV/CQV Validation Specialist to support qualification and validation activities at a regulated biopharmaceutical manufacturing site. This hands-on role will support both Computerized System Validation (CSV) and Commissioning, Qualification & Validation (CQV) activities, with a focus on analytical laboratory instruments, computerized systems, and GMP equipment.
Key Responsibilities
- Develop, execute, review, and maintain validation lifecycle documentation, including URS, risk assessments, specifications, traceability matrices, test scripts, protocols, deviations, CAPAs, change controls, and validation reports.
- Support and execute IQ/OQ/PQ activities for analytical instruments, computerized systems, and GMP equipment.
- Verify calibration readiness, data integrity, 21 CFR Part 11, EU Annex 11/15, and cGMP compliance.
- Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners.
- Support validation software platforms such as Kneat or similar e-validation systems.
- Monitor field execution, resolve discrepancies, maintain inspection-ready documentation, and support validation backlog remediation.
Required Qualifications
- 3 5+ years of CSV and/or CQV experience in pharmaceutical, biotechnology, medical, or another regulated industry.
- Hands-on experience with analytical laboratory instrument qualification and GMP equipment qualification.
- Strong understanding of IQ/OQ/PQ, GxP, cGMP, 21 CFR Part 11, EU Annex 11, and Annex 15.
- Experience managing multiple validation projects and competing priorities.
- Strong technical writing, documentation, organization, and cross-functional communication skills.
- Experience with Kneat or similar validation/documentation platforms is preferred.
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related discipline preferred.
Vacancy posted 3 days ago
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