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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