CQV Specialist - Packaging Equipment

Pinnaql, Inc.; New Albany, Northern (OH, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a CQV Specialist - Packaging Equipment to support commissioning, qualification, and validation activities for packaging lines in a biotechnology manufacturing environment.

This onsite opportunity is based in New Albany, OH. The role requires a Bachelor’s degree in Engineering or Life Sciences, 5+ years in CQV or validation, and experience with packaging equipment such as labelers, cartoners, and serialization systems.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of CQV, validation, or commissioning experience in pharma/biotech.
• 2+ years qualifying packaging line equipment (fillers, labelers, cartoners, serialization).
• Strong knowledge of cGMP and FDA requirements.
• Experience writing validation docs (IQ/OQ/PQ, reports).

Responsibilities

• Support CQV activities for packaging equipment and systems.
• Develop, review, and execute IQ/OQ/PQ protocols.
• Verify installation and readiness of packaging equipment like labelers and cartoners.
• Coordinate with engineering, QA, validation, manufacturing, and vendors.
• Support deviations and documentation updates.
• Assist with risk assessments and validation strategies.
• Ensure compliance with regulatory requirements and company procedures.
• Support FAT/SAT, startup, and troubleshooting.
• Maintain documentation and turnover packages for validated systems.

Skills

Technical writing

Documentation

Cross-functional collaboration

Team collaboration

Education

Bachelor's degree

Tools

IQ/OQ/PQ protocols

FAT/SAT

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a 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.

This is a contract opportunity available on a W-2 or 1099 basis. Candidates must be authorized to work for any employer in the U.S. without a current or future need for visa sponsorship.

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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.