CQV Specialist

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 talented, dedicated individual committed to work under the highest ethical standards for the following position:

• CQV Specialist

Summary:
We are seeking a CQV Specialist to support commissioning, qualification, and validation activities for sterile liquid pharmaceutical manufacturing and packaging equipment and systems. The role will primarily support packaging and solution preparation systems, while also assisting with related validation activities for equipment, utilities, facilities and manufacturing processes as needed.

This position is ideal for a motivated, hands-on professional who can support protocol development and field execution activities in a GMP-regulated manufacturing environment while working closely with an experienced validation team.

Responsibilities:

• Support commissioning, qualification, and validation activities for packaging equipment, including fillers, cappers, labelers, conveyors, vision systems, and related process equipment.
• Assist 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. This position does not offer remote or hybrid work options, and candidates must be willing to support activities at client site locations as required.

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.

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