What are the responsibilities and job description for the ATL02-062425 CQV Engineer Fill/Finish and Analytical Equipment (PA) position at Validation & Engineering Group?
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other technical services.
We are currently seeking a CQV Engineer with expertise in laboratory systems, QC modules, and aseptic fill/finish equipment to support commissioning and qualification activities in support of GMP operations. The selected candidate must be available to work in cleanroom, laboratory, and classified areas, complying with all safety, gowning, and documentation standards.
Location: Spring House, PA
Responsibilities:
- Author, review, and execute risk-based qualification protocols (IQ, OQ, PQ) for:
- QC modules: Flow Cytometry, Cell Count, Reagent Fill, Ambient and Cold Storage.
- Laboratory equipment: Biosafety cabinets, isolators, centrifuges, balances, peristaltic pumps, air samplers.
- Aseptic fill/finish systems: Vial filling modules, isolators, cappers, crimpers, inspection systems.
- Lead system walkdowns, protocol execution, and traceability matrix development.
- Coordinate FAT/SAT support and ensure test readiness for system turnover.
- Collaborate with automation, operations, and quality stakeholders to align timelines and mitigate issues.
- Support deviation documentation and protocol closure per project requirements.
Qualifications:
- Bachelors degree in life sciences, engineering, or related field.
- Minimum 5 years of CQV experience in a GMP lab, QC, or aseptic fill/finish setting.
- Strong knowledge of qualification strategies for lab, QC, and drug product systems.
- Experience with barrier systems, inspection technologies, and integrated QC modules.
- Excellent documentation, troubleshooting, and cross-functional coordination skills.