Downstream CQV Engineer

Zachary Piper Solutions; Holly Springs (NC); On-site; USD 76,000 - 103,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Job summary

Piper Companies seeks a Downstream CQV Engineer in Holly Springs, NC for a contract role supporting commissioning, qualification, and validation of downstream processing equipment in a large-scale biologics facility.

Responsibilities include performing IV/OV/PQ, field walkdowns, P&ID reviews, and documenting validation activities in compliance with GMP standards.

Qualifications

• 2+ years of CQV, validation, process engineering, or related GMP-regulated environments.
• Experience supporting at least two phases of the qualification lifecycle (IV/OV/PQ).
• Strong understanding of downstream bioprocessing equipment and operations.

Responsibilities

• Execute IV, OV, and PQ protocols for downstream systems.
• Perform field walkdowns, inspections, and P&ID reviews for readiness.
• Support qualification activities for chromatography, ultrafiltration, buffers, and bulk fill.

Skills

CQV experience

GMP understanding

Process engineering

Documentation

Tools

DeltaV

Kneat

Job description

Piper Companies is seeking a Downstream CQV Engineer to join a leading organization within the biotechnology manufacturing industry for a contract opportunity in Holly Springs, North Carolina. The Downstream CQV Engineer will support commissioning, qualification, and validation activities for downstream processing equipment and manufacturing systems within a large-scale biologics production environment, helping drive startup and operational readiness initiatives.

Responsibilities of the Downstream CQV Engineer include:

• Execute Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) protocols for downstream manufacturing systems.
• Perform field walkdowns, equipment inspections, and P&ID reviews to verify proper installation, configuration, and system readiness.
• Support qualification activities for downstream process equipment including chromatography systems, ultrafiltration units, buffer preparation systems, and bulk fill operations.
• Utilize DeltaV or similar control systems to execute testing activities, assess system functionality, and assist with troubleshooting during commissioning and qualification efforts.
• Prepare, review, and maintain validation documentation while ensuring compliance with GMP requirements and project quality standards.

Qualifications for the Downstream CQV Engineer include:

• 2+ years of experience in CQV, validation, process engineering, or related GMP-regulated manufacturing environments.
• Experience supporting at least two phases of the qualification lifecycle, including IV, OV, and/or PQ execution.
• Strong understanding of downstream bioprocessing equipment and manufacturing operations.
• Ability to interpret P&IDs, conduct system walkdowns, and troubleshoot process or mechanical equipment issues.
• Experience with DeltaV, Kneat, or similar automation and validation platforms is preferred.
• Strong communication, organizational, and technical documentation skills with the ability to succeed in a fast-paced facility startup environment.

Compensation for the Downstream CQV Engineer:

• Pay Range: $55-$75/hour
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 9/25/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: downstream CQV engineer, commissioning, qualification, validation, IV, installation verification, OV, operational verification, PQ, performance qualification, downstream processing, biotechnology manufacturing, biologics, chromatography systems, ultrafiltration, buffer preparation, bulk fill, DeltaV, Kneat, GMP, startup facility, process engineering, field execution, equipment qualification, validation protocols, manufacturing operations, troubleshooting, system walkdowns, P&ID review, process validation, GMP documentation, CQV lifecycle, engineering support, automation systems.