Job Description
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.
Prov...
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.
Prov...
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