Downstream CQV Engineer - 175521

About the role

Piper Companies is seeking a Downstream CQV Engineer to support a growing client in the biologics manufacturing industry in Holly Springs, NC. The role requires working onsite full-time within a greenfield biologics manufacturing facility. It 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

• 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

• 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.

Benefits

• Health insurance
• Vision insurance
• Dental insurance
• Paid time off (PTO)
• Paid holidays
• Sick leave (if required by law)

Pay

$110,000 - $130,000 annually

Schedule

Full-time, onsite