Downstream CQV Engineer – Biologics GMP Validation (Onsite)

Piper Companies; Holly Springs (NC); On-site; USD 84,000 - 129,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Sick leave

401K

Job summary

Piper Companies seeks a Downstream CQV Engineer to join a biologics manufacturing organization in Holly Springs, NC, onsite for a long-term contract. You will support commissioning, qualification, and validation across downstream processing systems to ensure readiness for production in a greenfield facility.

Candidates should have 5+ years in CQV/validation within GMP, hands-on field verification, and the ability to interpret P&IDs and perform system walkdowns.

Qualifications

• 5+ years in CQV, validation, or process engineering within a GMP setting.
• Exposure to at least two phases of CQV lifecycle such as IV, OV, or PQ.
• Strong field-based experience with equipment verification and start-up.
• Ability to interpret P&ID diagrams and perform detailed system walkdowns.
• Detail-oriented and proactive mindset for troubleshooting mechanical/process systems.

Responsibilities

• Carry out commissioning and qualification tasks across IV, OV, and PQ activities for process equipment.
• Perform hands-on system checks, field verification, and walkthroughs for validation readiness.
• Lead and assist with P&ID reviews and line walkdowns to confirm system accuracy.
• Support execution activities on downstream equipment including buffers, chromatography skids, ultrafiltration units, and bulk fill operations.
• Troubleshoot mechanical and process issues in real time with cross-functional teams.

Skills

CQV/validation

Field execution

P&ID interpretation

GMP knowledge

Troubleshooting

Tools

DeltaV

HMI

Kneat

Job description

Piper Companies seeks a Downstream CQV Engineer to join a biologics manufacturing organization in Holly Springs, NC, onsite for a long-term contract. You will support commissioning, qualification, and validation across downstream processing systems to ensure readiness for production in a greenfield facility.

Candidates should have 5+ years in CQV/validation within GMP, hands-on field verification, and the ability to interpret P&IDs and perform system walkdowns.