CQV Engineer

Shoolin Inc; California (MO); On-site; USD 90,000 - 120,000; Part time

Job summary

A pharmaceutical company located in California is seeking a Mid-Senior level CQV Engineer to lead various commissioning activities for critical utility systems in a GMP-regulated environment. The ideal candidate should have over 3 years of experience in pharmaceutical commissioning with a strong focus on compliance and quality. A Bachelor's degree in Engineering is required along with hands-on experience in utility systems like WFI and HVAC. This contract position emphasizes collaboration with cross-functional teams to ensure project success.

Qualifications

• 3+ years of pharmaceutical commissioning experience.
• Hands-on commissioning of critical utility systems.
• Strong knowledge of GMP and Pharmaceutical Quality System.

Responsibilities

• Lead commissioning of utility systems in a GMP environment.
• Ensure compliance with GMP requirements.
• Develop QRM deliverables, including risk assessments.

Skills

Pharmaceutical commissioning experience

Hands-on commissioning of critical utility systems

GMP and Pharmaceutical Quality System knowledge

Quality Risk Management (QRM)

Knowledge of ASTM E2500

Education

Bachelor’s degree in Engineering (Mechanical, Chemical, or Process)

Job description

CQV Engineer

Seeking an experienced Pharmaceutical Commissioning Engineer to lead commissioning activities for critical utility systems in a GMP-regulated pharmaceutical environment. The role focuses on risk-based commissioning, quality compliance, and delivery of fully documented, compliant utility systems.

Required Experience

• 3+ years of pharmaceutical commissioning experience
• Hands-on commissioning of critical utility systems (WFI, Clean Steam, HVAC, Autoclaves)
• Strong GMP and Pharmaceutical Quality System knowledge
• Experience with Quality Risk Management (QRM) and risk assessments
• Working knowledge of ASTM E2500 (risk-based commissioning/qualification)
• Bachelor’s degree in Engineering (Mechanical, Chemical, or Process)

Key Responsibilities

• Lead commissioning of non-impact and impact utility systems, including industrial water, sanitary waste, refrigerated water, WFI generation and distribution, clean steam, autoclaves, and cleanroom HVAC (Grade B & C).
• Ensure all commissioning activities comply with GMP and Pharmaceutical Quality System requirements.
• Develop and execute QRM deliverables, including risk assessments and mitigation strategies.
• Prepare, review, and approve commissioning protocols, documentation, and final reports.
• Collaborate with cross-functional teams to support timely project execution and system handover.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Pharmaceutical Manufacturing