Downstream CQV Engineer - 175521

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

Benefits offered by this job

Health insurance

Vision and Dental

Paid time off

Job summary

Piper Companies in Holly Springs, NC, is seeking a Downstream CQV Engineer to support a greenfield biologics manufacturing facility. This onsite, full-time role targets professionals with 2–5 years of CQV experience, focusing on IQ/OQ/PQ execution and field activity on the manufacturing floor during startup and qualification.

The ideal candidate will work closely with engineering, manufacturing, and quality teams to ensure smooth handover from construction to qualification, while maintaining GMP

Qualifications

• 2-5 years of CQV experience in pharma/biotech
• Hands-on execution of IQ/OQ/PQ protocols
• Strong field execution on manufacturing floor

Responsibilities

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

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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