Senior CSV Engineer

KPC International - Excellence from Concept to Completion

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up, from Strategy and Planning through to Execution and Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients.

CSV Engineer

We are seeking a Computer System Validation (CSV) Engineer to support validation activities across pharmaceutical manufacturing and laboratory systems, ensuring compliance with GMP, GAMP 5, Annex 11, and 21 CFR Part 11 requirements.

Key Responsibilities

• Execute CSV lifecycle activities, including URS, risk assessments, IQ/OQ/PQ, traceability, and validation reports
• Ensure compliance with data integrity, GMP, and regulatory standards
• Support FAT, SAT, commissioning, and qualification of automated systems
• Manage change controls, deviations, and CAPAs for validated systems
• Collaborate with Engineering, QA, Automation, Production, and Vendors
• Support audits and inspections with complete validation documentation

Systems in Scope

• Production Autoclave, Parts Washer, Lab Autoclave, Lab Isolator
• Filling Line Isolators (4 systems), including VHP and HVAC integration
• Filling Machine with CIP/SIP, Capping Machine, External Washer, Tray Loader

Requirements

• Degree in Engineering, Life Sciences, Automation, or related field
• 3+ years’ experience in CSV/CQV within pharma, biotech, or medical devices
• Experience validating automated equipment and control systems
• Strong knowledge of GMP, GAMP 5, and regulatory validation requirements
• Experience with aseptic/filling or isolator-based systems is highly desirable

Skills

• Strong documentation and validation protocol writing
• Risk-based validation approach
• Cross-functional collaboration
• Strong attention to detail and compliance mindset

KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.KPC – International is an Equal Opportunity Employer.

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