KPC International
CSV Engineer
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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