Downstream CQV Engineer - 175521

Piper Companies; Holly Springs (NC); On-site; USD 110,000 - 130,000; Full time

Job summary

Piper Companies seeks a Downstream CQV Engineer to support a growing biologics program in Holly Springs, NC. This on-site, full-time role focuses on commissioning, qualification, and validation of downstream process equipment within a greenfield facility.

The candidate will execute IQ/OQ/PQ protocols, work on the manufacturing floor during startup, and ensure GMP compliance while collaborating with engineering, quality, and project teams.

Qualifications

• 2-5 years of CQV experience in pharma/biotech life sciences environments.
• Hands-on IQ/OQ/PQ protocol execution for process equipment and systems.
• Strong field execution on the manufacturing floor during startup and qualification.

Responsibilities

• Execute commissioning, qualification, and validation activities for downstream equipment and supporting systems.
• Perform IQ, OQ, and PQ protocol execution, documentation, and troubleshooting.
• Partner with engineering, manufacturing, quality, and projects teams to transition systems from construction to qualification.
• Support field verification, walkdowns, punch list resolution, and turnover package reviews during startup.
• Ensure CQV activities comply with GMP requirements and site procedures.

Skills

CQV experience

IQ/OQ/PQ

GMP compliance

Field execution

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related

Job description

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 10/2/2026. 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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