CQV Specialist

Responsibilities

• Support commissioning, qualification, and validation activities for packaging equipment, including fillers, cappers, labelers, conveyors, vision systems, and related process equipment.
• Afford assistance with qualification activities for solution preparation systems, utilities, facilities and supporting manufacturing systems as needed.
• Develop, execute, and support validation documentation, including risk assessments, FAT/SAT protocols, IQ/OQ/PQ protocols, and summary reports.
• Provide hands-on support during protocol execution and field verification activities.
• Support troubleshooting efforts, deviation resolution, and documentation updates during validation execution.
• Work closely with engineering, manufacturing, quality, and validation teams to support project timelines and execution priorities.
• Ensure validation deliverables comply with cGMP requirements, FDA expectations, and internal procedures.

Qualifications

• Bachelor’s degree in Engineering, Biology, Chemistry, Microbiology, or other related Natural Science discipline.
• At least 3–5 years of CQV experience within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Experience supporting IQ/OQ/PQ protocol development and execution activities.
• Packaging equipment validation experience preferred; however, strong equipment CQV experience will also be considered.
• Experience with Kneat or electronic validation systems preferred.
• Working knowledge of cGMP regulations and validation lifecycle practices.
• Strong organizational, communication, and technical writing skills.
• Ability and willingness to work fully on-site in a fast-paced manufacturing environment.