Downstream CQV Engineer

Piper Companies is seeking a Downstream CQV Engineer to join an established biopharmaceutical manufacturing organization for an onsite contract position in the Holly Springs, North Carolina area. The Downstream CQV Engineer will play a critical role supporting commissioning, qualification, and validation efforts within a newly built biologics production facility, with a primary emphasis on downstream processing systems.

Responsibilities of the Downstream CQV Engineer:

·      Execute commissioning and qualification protocols including installation, operational, and performance activities for processing equipment

·      Perform field-based system checks, equipment verification, and P&ID walkthroughs to confirm proper installation and readiness

·      Support troubleshooting and resolution of equipment or process issues encountered during validation activities

·      Assist with downstream system qualification including chromatography, filtration, buffer prep, and bulk handling processes

·      Prepare and review validation documentation while ensuring compliance with GMP standards and internal procedures

Qualifications for the Downstream CQV Engineer:

·      2–5 years of experience in CQV, validation, or process engineering within a regulated manufacturing environment

·      Hands-on experience supporting at least two phases of validation (installation, operational, or performance)

·      Ability to interpret engineering diagrams such as P&IDs and perform system walkdowns

·      Strong troubleshooting skills with mechanical systems or process equipment

·      Experience with downstream processing systems or exposure to DeltaV or similar automation platforms preferred

Compensation for the Downstream CQV Engineer:

·      $135,000 - $185,000 at an hourly pay rate

·      Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law

Keywords: CQV engineer, commissioning, qualification, validation, downstream processing, GMP, P&ID, DeltaV, chromatography, ultrafiltration, buffer preparation, biologics manufacturing, system verification, troubleshooting, field execution, process validation, pharmaceutical engineering, clean utilities, automation systems, FDA compliance, documentation, validation protocols, engineering support, startup facility experience

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This job opens for applications on 7/10/26. Applications for this job will be accepted for at least 30 days from the posting date.