CQV Engineer

Intellectt Inc; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt Inc is looking for experienced CQV Engineers for a large-scale greenfield biopharmaceutical manufacturing project located in North Carolina. The role involves executing commissioning, qualification, and startup activities for GMP manufacturing equipment and supporting critical utilities like WFI and HVAC. Ideal candidates should have over 5 years in CQV/Startup within the pharmaceutical industry and possess strong documentation skills. The environment is dynamic, and engineers are expected to drive project timelines effectively.

Qualifications

• 5+ years of CQV/Startup experience in pharmaceutical, biotech, or life sciences industries.
• Strong experience in greenfield facility projects.
• Ability to independently execute qualification and startup activities.

Responsibilities

• Execute commissioning, qualification, and startup activities for GMP manufacturing equipment.
• Develop and execute IQ/OQ protocols and commissioning test plans.
• Support startup and troubleshooting of process equipment and clean utility systems.

Skills

CQV/Startup experience

Experience supporting critical utilities

Strong GMP documentation skills

Excellent communication skills

Education

Bachelor’s degree in Engineering or related technical discipline

Tools

DeltaV

Rockwell

Kneat

ValGenesis

Job description

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

• Experience with DeltaV, Rockwell, or other automation systems.
• Prior experience with biologics or sterile manufacturing facilities.
• Familiarity with Kneat, ValGenesis, or electronic validation systems.
• Bachelor’s degree in Engineering orrelated technical discipline