Filling Line CQV Engineers

KPC International - Excellence from Concept to Completion KPC International began operations in 2001. Our team of engineers and scientists has helped our clients achieve project success across the globe within the pharmaceutical and biopharmaceutical industry. 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 life-changing therapies to patients Commissioning, Qualification, and Verification (CQV) Engineers with filling line experience, protocol execution, system walk-downs, aseptic processing and regulatory compliance required for our new office which located in Hyderabad, India KEY RESPONSIBILITIES Protocol Lifecycle: Author, review, and execute User Requirement Specifications (URS), Factory/Site Acceptance Tests (FAT/SAT), and Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols for sterile fill-finish systems.Aseptic Execution: Oversee testing of liquid/lyophilized vial, syringe, or cartridge filling machines, isolators, and restricted-access barrier systems (RABS).Compliance & Quality: Ensure compliance with cGMP, FDA, EMA, and EU Annex 1 guidelines, managing real-time deviations and punch-list resolutions.Cross-Functional Collaboration: Perform P&ID walk-downs and coordinate with validation, automation, and operations teams during startup and handover. SKILL AND EXPERIENCE Education: Bachelor's degree in mechanical, Chemical, Biopharmaceutical Engineering, or a related science discipline.Experience: 5+ years of dedicated CQV experience within a regulated pharmaceutical or biopharmaceutical environment.Specialized Knowledge: Direct, hands-on exposure to sterile manufacturing, fill-finish operations, and associated clean utilities (WFI, Clean Steam, HVAC).Technical Tools: Familiarity with paperless/electronic validation systems like Kneat or ValGenesis. Why Join KPC International Join a growing international team supporting some of the world's leading pharmaceutical and biotechnology companies. You'll have the opportunity to work on major global capital projects while developing your technical expertise across commissioning, qualification and validation activities. KPC International offers an inclusive environment where you can broaden your experience, work alongside industry experts, and contribute to the successful delivery of life-changing medicines. KPC International is an Equal Opportunity Employer. #LI-BC1 .