Lead CSV Engineer

Lead CSV Engineer
Greenfield Pharmaceutical Manufacturing Site

Kerry Consulting is partnering with a leading pharmaceutical manufacturer to appoint a Lead Computer System Validation (CSV) Engineer for a major greenfield production facility.

This is a critical role supporting the implementation and validation of GxP-regulated systems from design through commissioning and operational readiness. You will lead the validation strategy across manufacturing, laboratory, and enterprise systems, ensuring compliance, data integrity, and inspection readiness from day one.

Key focus areas:

• Validation of DCS / PLC / SCADA systems
• MES, LIMS and enterprise GxP systems
• 21 CFR Part 11 & Annex 11 compliance
• Data Integrity (ALCOA+) governance
• Validation lifecycle aligned to GAMP5
• FAT/SAT oversight and CQV collaboration
  
  Requirements:
• 10+ years CSV experience within pharmaceutical or GMP-regulated environments
• Proven experience supporting greenfield or major expansion projects
• Strong understanding of risk-based validation principles
• Experience leading validation documentation (URS, FS/DS, IQ/OQ/PQ, traceability matrices)
• Ability to interface with Automation, IT, Engineering, and Quality stakeholders

Please submit your resume in Word or PDF format to Tahmid Bin Zafar at [Confidential Information], quoting the job title and reference no TZ34994. We regret that only shortlisted candidates will be notified.

Desired Skills and Experience

10+ years CSV experience within pharmaceutical or GMP-regulated environments

Proven experience supporting greenfield or major expansion projects