CQV Engineer

Pioneer GMP Consulting • Chicago, IL

2d • Onsite

About The Position

Pioneer GMP Consulting is seeking a Mid-Level CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotech manufacturing projects in the Chicago area. This onsite role will support GMP facilities, utilities, equipment, and manufacturing systems through the full project lifecycle—from startup and commissioning through qualification and validation execution. The ideal candidate has hands-on CQV experience within GMP-regulated environments and is comfortable working cross-functionally with Engineering, Manufacturing, Quality, Automation, and project teams in fast-paced client environments. This role is best suited for someone who enjoys balancing technical execution with a strong consultative approach and thrives in highly collaborative manufacturing settings.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline
• 3–7+ years of experience supporting CQV, validation, commissioning, or qualification activities within GMP-regulated pharmaceutical or biotech manufacturing environments
• Strong understanding of cGMP requirements, FDA regulations, validation lifecycle principles, and industry best practices
• Experience executing or supporting IQ/OQ/PQ protocols for GMP facilities, utilities, equipment, or manufacturing systems
• Familiarity with commissioning, startup, turnover, and operational readiness activities
• Strong technical writing and documentation skills
• Ability to work independently in a client-facing consulting environment while managing multiple priorities
• Comfortable performing onsite field activities and collaborating across cross-functional teams
• Strong communication, organization, and problem-solving skills
• Ability to work onsite in the Chicago area

Nice To Haves

• Strong consultative approach with the ability to partner effectively across Engineering, Manufacturing, Quality, and leadership teams while delivering practical, compliance-focused solutions
• Experience supporting large capital projects, facility startups, or manufacturing expansions
• Experience within biologics, aseptic processing, cell & gene therapy, or other advanced therapy manufacturing environments
• Familiarity with clean utilities, HVAC systems, automation systems, or process equipment qualification
• Experience with Kneat, ValGenesis, Blue Mountain, or other electronic validation/documentation systems
• Ability to translate technical and compliance requirements into clear, practical documentation and actionable solutions
• Thrives in structured, detail-oriented environments where quality, compliance, and execution are critical
• Proactively identifies gaps, drives continuous improvement, and supports operational excellence initiatives
• Builds strong relationships and represents Pioneer with professionalism, credibility, and accountability
• Prior consulting experience within regulated pharmaceutical or biotech manufacturing environments
• Experience supporting FDA inspection readiness, audit support, or remediation initiatives

Responsibilities

• Execute commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and systems
• Develop, execute, and review IQ/OQ/PQ protocols and validation documentation
• Support commissioning and startup activities for manufacturing equipment and process systems
• Participate in field verification, system walkdowns, discrepancy resolution, and turnover activities
• Review vendor documentation, turnover packages, and test documentation to ensure project readiness and compliance
• Coordinate with Engineering, Manufacturing, Quality Assurance, Automation, and project teams to support successful project execution
• Support deviation investigations, change controls, CAPAs, and risk assessments as needed
• Ensure compliance with FDA regulations, cGMP requirements, ISPE guidance, and client quality standards
• Maintain accurate project documentation and validation traceability throughout the project lifecycle
• Communicate project updates, technical findings, and recommendations clearly to client stakeholders
• Support operational readiness, facility expansions, and continuous improvement initiatives within GMP manufacturing environments

Benefits

• Compensation for this position is commensurate with experience, qualifications, technical expertise, and overall alignment with the needs of the role and client environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level