CQV Specialist - Packaging Equipment

Pinnaql, Inc.; New Albany (OH); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Validation & Engineering Group, Inc. (a Pinnaql company) seeks a CQV Specialist - Packaging Equipment to support commissioning, qualification, and validation in a biotechnology manufacturing setting.

This on-site role in New Albany, OH focuses on package lines, labeling, serialization, and related systems, ensuring cGMP and FDA compliance throughout the validation lifecycle. You will develop and review IQ/OQ/PQ protocols, verify equipment readiness, and collaborate with engineering, quality,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CQV

Validation

Documentation

Cross-functional collaboration

Technical writing

Formazione

Bachelor’s degree in Engineering, Life Sciences, or related technical discipline

Descrizione del lavoro

Current job opportunities are posted here as they become available.

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 who will 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.

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.
Excited to build something meaningful together? We look forward to hearing from you.
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.