CQV Engineer Job Irvine area,California USA,Engineering

Job Summary

We are seeking experienced CQV Engineers for a large-scale greenfield biopharmaceutical manufacturing project in North Carolina. The ideal candidates will have strong hands-on commissioning, qualification, and validation experience supporting upstream/downstream process equipment and critical utility systems within GMP-regulated environments.
Candidates should be capable of working independently with minimal supervision and collaborating effectively with cross-functional engineering, manufacturing, and quality teams during facility startup and operational readiness activities.

Key Responsibilities

Execute commissioning, qualification, and startup activities for GMP manufacturing equipment and utility systems.
Develop and execute IQ/OQ protocols, commissioning test plans, and system turnover packages.
Support startup and troubleshooting of process equipment and clean utility systems.
Coordinate with engineering, automation, validation, and operations teams during project execution.
Review P&IDs, design documents, vendor packages, and system impact assessments.
Ensure compliance with GMP, GDP, and regulatory requirements.
Support deviation investigations, punch list resolution, and change control activities.
Participate in walkdowns, FAT/SAT activities, and mechanical completion verification.
Drive schedule adherence while supporting aggressive project timelines.

Required Experience

5+ years of CQV/Startup experience in pharmaceutical, biotech, or life sciences industries.
Strong experience in greenfield facility projects.
Experience supporting critical utilities including:
WFI
Clean Steam
HVAC
Compressed Air
Purified Water
CIP/SIP systems
Experience with upstream and downstream process equipment.
Ability to independently execute qualification and startup activities.
Strong GMP documentation and protocol execution experience.
Excellent communication and coordination skills.

Preferred Qualifications

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