Onsite Downstream CQV Engineer – Biologics GMP

ZP Group; Holly Springs (NC); On-site; USD 128,000 - 195,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Job summary

Piper Companies seeks a highly experienced Downstream CQV Engineer for a fully onsite, long-term contract in Holly Springs, NC. You will support commissioning, qualification, and validation activities across downstream processing systems in a new facility with hands-on field execution.

Key qualifications include 5+ years in CQV/validation within GMP settings, experience in IV/OV/PQ phases, strong P&ID interpretation, and proven troubleshooting skills. DeltaV and HMI experience preferred.

Qualifications

• 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.

Responsibilities

• 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&ID reviews 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.

Skills

CQV experience

Validation

Process engineering

GMP

P&ID interpretation

Troubleshooting

Tools

DeltaV

HMI

Job description

Piper Companies seeks a highly experienced Downstream CQV Engineer for a fully onsite, long-term contract in Holly Springs, NC. You will support commissioning, qualification, and validation activities across downstream processing systems in a new facility with hands-on field execution.

Key qualifications include 5+ years in CQV/validation within GMP settings, experience in IV/OV/PQ phases, strong P&ID interpretation, and proven troubleshooting skills. DeltaV and HMI experience preferred.