CSV C&Q Lead – GxP
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a Senior CSV / C&Q Lead with deep expertise in GxP Computer System Validation and Commissioning & Qualification across pharmaceutical manufacturing environments. The role requires strong hands-on experience across the full CSV and C&Q lifecycle leadership in regulated automation programs and the ability to partner effectively with Quality Engineering IT and Operations teams.
- Lead and execute end-to-end CSV and C&Q activities across the full lifecycle:
- URS Risk Assessment IQ / OQ / PQ UAT System Release Retirement
- Define and review validation strategies plans and execution models aligned with GxP and regulatory expectations.
- Ensure robust risk-based validation approaches in line with GAMP 5 principles.
Required Qualifications & Experience
- Bachelors degree in Engineering Computer Science Life Sciences or related discipline.
- 10 years of experience in CSV C&Q and GxP system validation within pharmaceutical or biopharma manufacturing.
- Proven experience validating automation platforms (DeltaV PLC SCADA BAS/HMI).
- Strong command of GxP regulations GAMP 5 SDLC data integrity and validation best practices.
- Hands-on experience with Kneat Gx and structured validation documentation.
- Excellent stakeholder management and leadership skills.
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
