CQV Engineer Downstream

Piper Companies is seeking a CQV Engineer (Downstream DSM 3 & 4) to support commissioning, qualification, and validation efforts within a cutting-edge biologics manufacturing environment. The CQV Engineer (Downstream DSM 3 & 4) role is ideal for a hands-on professional with strong field execution experience and a background in downstream bioprocessing systems within a GMP-regulated setting.

Responsibilities of the CQV Engineer (Downstream):

• Execute Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) protocols.
• Perform field verification activities to confirm proper installation and system readiness for qualification.
• Lead and support P&ID walkdowns to ensure alignment, completeness, and compliance of systems.
• Support end-to-end CQV lifecycle from initial documentation through field execution.
• Qualify downstream bioprocessing systems including buffer prep/hold, chromatography skids, UF systems, and bulk fill systems.
• Execute OV activities using DeltaV systems, including valve operations and HMI interface controls.
• Troubleshoot and resolve mechanical or process-related issues during execution.
• Collaborate on PQ activities including buffer hold studies and process criteria verification.
• Generate and execute CQV documentation including protocols, test scripts, and summary reports.
• Ensure all documentation meets GMP standards for accuracy and completeness.
• Participate in document review cycles and revisions as needed.
• Collaborate across IV, OV, and PQ teams to support shared execution goals in a startup environment.
  
  

Qualifications of the CQV Engineer (Downstream):

• 2–5 years of CQV, validation, or process engineering experience within a GMP environment.
• Experience in at least two of the following: IV, OV, PQ.
• Strong hands-on field execution experience, including equipment and system verification.
• Ability to read and interpret P&IDs and perform system walkdowns.
• Experience troubleshooting mechanical or process systems in a live environment.
• Strong attention to detail with excellent documentation and observational skills.
• Experience with downstream bioprocessing systems highly preferred.
• Exposure to upstream processing, utilities (WFI, clean steam), or drug product/fill-finish operations is a plus.
• Familiarity with DeltaV control systems and/or Kneat digital validation platforms preferred.
• Prior experience supporting greenfield or startup manufacturing facilities is a plus.
• Strong communication skills with the ability to collaborate across cross-functional teams.
  
  

Compensation for the CQV Engineer (Downstream) includes:

• Salary range: $110,000 - $150,000
• Comprehensive benefits package including medical, dental, vision, and retirement plans
• Opportunity to work in a high-growth, state-of-the-art biologics manufacturing environment
• Career advancement within a rapidly expanding life sciences organization
  
  

This job opens for applications on 06/28/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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