CQV Specialist - Packaging Equipment

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.
• Cookordinate 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.