Downstream CQV Engineer
Listed on 2026-10-05
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Engineering
Validation Engineer, Quality Engineering, Regulatory Compliance Specialist
Piper Companies is seeking a Downstream CQV Engineer to join a biologics manufacturing organization for a fully onsite, long-term contract position located in Holly Springs, NC. The Downstream CQV Engineer will play a critical role in commissioning, qualification, and validation efforts within a newly built production facility, supporting downstream processing systems and ensuring operational readiness across multiple CQV phases.
Responsibilities for the Downstream CQV Engineer include:- Carry out commissioning and qualification tasks across Installation Verification, Operational Verification, and Performance Qualification activities for process equipment.
- Perform hands‑on system checks, field verification, and walkthroughs to confirm proper installation and readiness for validation efforts.
- Lead and assist with P& and line walkdowns to confirm system accuracy, completeness, and compliance with design intent.
- Support execution activities on downstream equipment including buffer systems, chromatography skids, ultrafiltration units, and bulk fill operations.
- Troubleshoot mechanical and process‑related issues in real time while collaborating with cross‑functional teams to resolve discrepancies during execution.
- 5+ years of experience in CQV, validation, or process engineering within a regulated GMP setting.
- Exposure to at least two phases of CQV lifecycle such as IV, OV, or PQ.
- Strong field‑based experience with equipment verification, system startup, and hands‑on execution work.
- Ability to interpret technical diagrams, especially P&IDs, and perform detailed system walkdowns.
- Background in troubleshooting mechanical or process systems with a detail‑oriented and proactive mindset.
- $128,000 - $195,000 paid at an hourly rate of $61.54/hr - $93.75/hr
- Comprehensive Benefits:
Medical, Dental, Vision, sick leave if required by law, and 401K
This job opens for applications on 8/21/26. Applications for this job will be accepted for at least 30 days from the posting date.
, P&, walkthroughs, troubleshooting, buffer preparation, chromatography, ultrafiltration, bulk fill, DeltaV, HMI, process validation, greenfield facility, equipment startup, Kneat, validation documentation, protocol execution, utilities, clean utilities, process systems, biotech, pharma manufacturing, quality compliance, technical operations, engineering support, system readiness, operational excellence, startup environment
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