Downstream CQV Engineer — Biologics GMP Validation Onsite

Zachary Piper Solutions; Holly Springs (NC); On-site; USD 128,000 - 195,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

Sick leave

Job summary

Piper Companies seeks a Downstream CQV Engineer for a fully onsite, long-term contract in Holly Springs, NC. You will lead commissioning, qualification, and validation activities for downstream processing systems in a new production facility.

Ideal candidates bring 5+ years in CQV/validation within GMP settings, strong field execution and P&ID interpretation skills, and the ability to collaborate across cross-functional teams to ensure operational readiness.

Qualifications

• 5+ years of experience 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, 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

Process engineering

GMP knowledge

Field execution

P&ID interpretation

Education

Bachelor's degree in Engineering

Tools

DeltaV

Kneat

HMI

Job description

Piper Companies seeks a Downstream CQV Engineer for a fully onsite, long-term contract in Holly Springs, NC. You will lead commissioning, qualification, and validation activities for downstream processing systems in a new production facility.

Ideal candidates bring 5+ years in CQV/validation within GMP settings, strong field execution and P&ID interpretation skills, and the ability to collaborate across cross-functional teams to ensure operational readiness.