Downstream CQV Engineer

Piper Companies is seeking a Downstream CQV Engineer to support a growing client in the biologics manufacturing industry in Holly Springs, NC. The Downstream CQV Engineer role requires working onsite full-time within a greenfield biologics manufacturing facility. The Downstream CQV Engineer role is ideal for a hands-on engineering professional with 2-5 years of experience supporting commissioning, qualification, and validation activities, with a strong focus on field execution and IQ/OQ/PQ protocols.

Responsibilities of the Downstream CQV Engineer include:

• Execute commissioning, qualification, and validation activities for downstream process equipment and supporting systems within a biologics manufacturing environment.

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol execution, documentation, and troubleshooting.

• Partner closely with engineering, manufacturing, quality, and project teams to ensure systems are transitioned effectively from construction through qualification.

• Support field verification activities, walkdowns, punch list resolution, and turnover package reviews during startup and commissioning phases.

• Ensure all CQV activities are conducted in compliance with GMP requirements, site procedures, and regulatory expectations.

Requirements of the Downstream CQV Engineer include:

• 2-5 years of experience supporting CQV activities within pharmaceutical, biotech, or life sciences manufacturing environments.

• Hands-on experience executing IQ, OQ, and PQ protocols for process equipment, utilities, or manufacturing systems.

• Strong field execution background with the ability to work directly on the manufacturing floor during startup and qualification activities.

• Familiarity with GMP regulations, validation lifecycle principles, and commissioning best practices.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

Compensation for the Downstream CQV Engineer include:

• $110,000 - $130,000 annually

• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.

• Opportunity to support a large-scale greenfield biologics manufacturing startup project.

• This job opens for applications on 09/30/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Downstream CQV Engineer, Commissioning Engineer, Validation Engineer, Qualification Engineer, CQV, Commissioning, Qualification, Validation, IQ, OQ, PQ, GMP, Biologics, Biotechnology, Pharmaceutical Manufacturing, Process Equipment, Greenfield, Startup Facility, Holly Springs, North Carolina

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