Downstream CQV Engineer – Onsite Greenfield Biologics

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 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.