CQV Engineer (Mid-Level)

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