CQV Specialist - Packaging Equipment whowill support commissioning, qualification, and validation activities for packaging equipment and systems in a biotechnology manufacturing environment. The role ensures that packaging lines are installed, tested, and documented in compliance with GMP, FDA, and internal quality requirements while supporting project schedules and startup activities. This is an onsite opportunity in New Albany, OH.
Key Responsibilities - Support commissioning, qualification, and validation (CQV) activities for primary and secondary packaging equipment and systems.
- Develop, review, and execute commissioning and qualification documentation including protocols such as IQ, OQ, and PQ.
- Verify installation and operational readiness of packaging equipment including labelers, cartoners, serialization systems, inspection systems, and associated utilities.
- Coordinate activities with engineering, quality assurance, validation, manufacturing, and vendors to ensure proper startup and qualification of packaging lines.
- Support protocol deviations, discrepancy resolution, and documentation updates as required.
- Assist with risk assessments, test planning, and validation strategies in accordance with project and regulatory requirements.
- Ensure compliance with cGMP, FDA regulations, and company validation procedures.
- Support FAT/SAT activities, startup, and troubleshooting during commissioning phases.
- Maintain accurate documentation and support turnover packages for validated systems.
Qualifications - Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
- 5+ years of experience in CQV, validation, or commissioning within pharmaceutical or biotechnology manufacturing environments.
- 2+ years of experience qualifying packaging line equipment such as fillers, labelers, cartoners, serialization/aggregation systems, vision inspection systems, and case packers.
- Strong knowledge of cGMP regulations, FDA requirements, and validation lifecycle practices.
- Experience writing and executing validation documentation (IQ/OQ/PQ, protocols, reports, discrepancies).
- Ability to work cross-functionally with engineering, quality, operations, and project management teams.
- Strong technical writing and documentation skills.
- Experience supporting equipment startup, FAT/SAT, and commissioning activities in a regulated environment.
- Available to work extended hours, possibility of weekends and holidays.
