GMP CQV Engineer – Life Sciences Validation Expert

Pioneer GMP Consulting; Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Pioneer GMP Consulting is seeking a CQV Engineer to support clients across GMP manufacturing environments in the Chicago area. You will operate as a trusted partner embedded within client operations while backed by Pioneer’s network of experts.

You’ll work on commissioning, qualification, and validation activities for facilities, utilities, and equipment, contributing to startups, capital projects, and readiness initiatives with strong emphasis on quality and regulatory readiness.

Qualifications

• 3–7+ years of CQV/validation/commissioning within GMP pharma or biotech environments.
• Strong understanding of cGMP, FDA regulations, and validation lifecycle principles.
• Experience executing IQ/OQ/PQ for GMP facilities, utilities, equipment, or systems.
• Familiarity with commissioning, startup, turnover, and operational readiness activities.
• Experience with clean utilities, HVAC, automation, or process equipment qualification.
• Experience supporting regulated manufacturing operations and facility projects.
• Strong technical writing, documentation, and independent client-facing work.

Responsibilities

• Support commissioning, qualification, and validation activities within GMP environments.
• Execute IQ/OQ/PQ protocols for facilities, utilities, equipment, and systems.
• Participate in equipment startup, system walkdowns, turnover and readiness activities.
• Identify and resolve discrepancies and documentation gaps during projects.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Automation, and project teams.
• Review GMP documentation, including protocols, reports, deviations, change controls, and SOPs.
• Ensure compliance with FDA, cGMP, ISPE guidance, and client quality standards.
• Support facility expansions, capital projects, and readiness initiatives.
• Communicate updates and findings clearly to client stakeholders.
• Contribute to continuous improvement for compliance and reliability.

Skills

CQV

Validation lifecycle

Commissioning

Qualification activities

GMP experience

Biotech experience

Regulatory awareness

Tools

Kneat

ValGenesis

Blue Mountain

Electronic validation systems

Job description

Pioneer GMP Consulting is seeking a CQV Engineer to support clients across GMP manufacturing environments in the Chicago area. You will operate as a trusted partner embedded within client operations while backed by Pioneer’s network of experts.

You’ll work on commissioning, qualification, and validation activities for facilities, utilities, and equipment, contributing to startups, capital projects, and readiness initiatives with strong emphasis on quality and regulatory readiness.