CQV Engineer (Chicago)

Pioneer GMP Consulting; Chicago, Northern (IL, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Pioneer GMP Consulting seeks a CQV Engineer to join our Chicago-area team, supporting commissioning, validation, and qualification activities across GMP systems and facilities for biopharma clients.

This is a long-term consulting opportunity with exposure to diverse technologies, manufacturing processes, and facility types throughout the life sciences industry. You’ll work embedded with client operations and collaborate with internal experts.

Qualifications

• 3–7+ years of CQV, validation, commissioning, or qualification within GMP-regulated pharma/biotech manufacturing.
• Strong understanding of cGMP, 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.
• Familiarity with clean utilities, HVAC, automation systems, or process equipment qualification.
• Experience supporting regulated manufacturing operations, facility projects, or capital expansions.
• Strong technical writing skills; documentation like protocols, reports, deviations, and validation documentation.
• Ability to work independently in a client-facing consulting environment while managing multiple priorities.
• Willingness to travel and work on-site in various locations.

Responsibilities

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

Skills

CQV

Validation

Commissioning

GMP compliance

IQ/OQ/PQ

Technical writing

Client-facing

On-site work

Cross-functional

Travel

Tools

Kneat

ValGenesis

Blue Mountain

Job description

Chicago, United States | Posted on 05/11/2026

Pioneer GMP Consulting is a specialized life sciences consultancy focused on delivering high-impact GMP compliance, validation, and quality system solutions to biopharmaceutical clients. We support startups, CDMOs, and global manufacturers across the product lifecycle, from clinical-stage development to commercial readiness.

We’re seeking a CQV Engineer to join our team at Pioneer GMP Consulting and support clients across pharmaceutical and biotech manufacturing environments in the Chicago area.

As part of our consulting team, you’ll operate as a trusted partner—embedded within client operations while remaining closely connected to and supported by Pioneer’s internal network of industry experts. You’ll play a key role in helping clients bring critical systems and facilities online safely, efficiently, and in compliance with GMP and regulatory expectations.

In this role, you’ll support commissioning, qualification, and validation activities across a wide range of GMP systems, equipment, utilities, and manufacturing environments. Your work may span facility startups, capital projects, equipment qualification, operational readiness initiatives, and ongoing manufacturing support. Success in this role requires strong technical expertise, attention to detail, problem-solving ability, and the confidence to collaborate with stakeholders across Engineering, Manufacturing, Quality, and Validation teams.

This is a long-term consulting opportunity—not a single project assignment. You’ll have the opportunity to contribute across multiple client engagements and gain exposure to diverse technologies, manufacturing processes, and facility types throughout the life sciences industry.

What You'll Do

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

Qualifications

• 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
  
• Familiarity with clean utilities, HVAC systems, automation systems, or process equipment qualification
  
• Experience supporting regulated manufacturing operations, facility projects, or capital expansions
  
• Ability to identify compliance, operational, and documentation gaps within GMP environments
  
• Strong technical writing skills, including protocol execution, report generation, deviations, and validation documentation
  
• Ability to work independently in a client-facing consulting environment while managing multiple priorities
  
• Comfortable performing onsite field activities, system walkdowns, and cross-functional collaboration with Engineering, Manufacturing, and Quality teams
  
• Strong communication, organization, and problem-solving skills
  
• Willingness to work onsite in the Cambridge/Boston area and support client project needs
  
• Willingness to travel and work on-site in various locations.
  

What Will Set You Apart

• Strong consultative mindset with the ability to build trust and collaborate effectively across client teams
  
• Experience supporting large capital projects, facility startups, or manufacturing expansions
  
• Experience within biologics, aseptic processing, cell & gene therapy, or other advanced therapy manufacturing environments
  
• 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
  

Competitive consulting rates commensurate with experience. Travel reimbursement and related expenses may apply depending on engagement requirements.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.