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.
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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