Commissioning & Qualification (C&Q) Engineer

Position Summary

The Commissioning & Qualification (C&Q) Engineer leads the integrated commissioning, qualification, and start-up of process equipment, utilities, and facility systems on capital projects. Using a risk-based, ASTM E2500-aligned approach, this role bridges engineering, validation, quality, and operations to deliver compliant, operational, and reliable assets ready for GMP use.

Key Responsibilities

• Develop integrated C&Q plans, schedules, and execution strategies aligned with project milestones and quality requirements.
  
• Lead system-level commissioning activities including pre-commissioning checks, loop checks, FAT/SAT, water flushing, passivation, leak testing, and functional testing.
  
• Author and execute Commissioning Test Plans (CTPs), System Impact Assessments (SIAs), Component Criticality Assessments (CCAs), and qualification protocols.
  
• Apply ASTM E2500 and ISPE Baseline Guide #5 (Commissioning and Qualification) for risk-based qualification strategies.
  
• Coordinate with construction, mechanical completion, vendors, and EPCM contractors to ensure systems are ready for turnover.
  
• Manage Turn-Over Packages (TOPs), punch lists, and walk-down activities through to system acceptance.
  
• Partner with Validation Engineering on protocol harmonization and leveraging commissioning data into qualification.
  
• Facilitate troubleshooting, root cause analysis, and resolution of system-level issues during start-up.
  
• Drive on-time, on-budget delivery of qualified systems ready for Process Performance Qualification (PPQ) and operations handover.
  
  

  Required Qualifications

• Bachelor's degree in Chemical, Mechanical, Electrical, or related Engineering discipline.
  
• 3–7 years of C&Q experience in pharmaceutical, biotech, or similar GMP regulated industry.
  
• Hands-on capital project experience executing commissioning and qualification on process equipment and utilities.
  
• Strong understanding of ASTM E2500, ICH Q9, ISPE Baseline Guide #5, and cGMP regulations.
  
• Experience leading FAT, SAT, and on-site commissioning activities.
  
• Excellent project management, documentation, and stakeholder communication skills.
  
  

  Preferred Qualifications

• Experience on greenfield or large brownfield expansion projects.
  
• API experience
  
• Experience with integrated/leveraged commissioning approaches.
  
• PMP or equivalent project management certification.
  
  

  Technical Skills

• Commissioning management software (Goal, BlueCielo, ProjectWise, or equivalent).
  
• Strong knowledge of P&ID interpretation, mechanical completion, and turnover processes.
  
• MS Project, Primavera P6, and MS Office suite.
  
  

  Why Join Us

• Work on greenfield and brownfield capital projects supporting next-generation therapeutics.
  
• Exposure to cutting-edge process technologies, single-use systems, and advanced automation platforms.
  
• Collaborative, safety-first, quality-driven culture committed to patient outcomes.
  
  

  Equal Opportunity Employer

  Hydrogen Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
  
  
  
  
  
  
  

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