CSV / C&Q Lead – GxP

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.