Senior Commissioning & Qualification (C&Q) Engineer

At-a-Glance:

Join a leading technology solutions and compliance consulting company as a Senior Commissioning & Qualification (C&Q) Engineer to advance your career.

Position Type:

• Contract
• Hybrid (2-3 days a week onsite)
  
  
  

Required:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biochemical Engineering, Pharmaceutical Engineering, Biotechnology, Microbiology, or a related field.
• Minimum 7 years of experience in commissioning, qualification, validation, or equipment engineering in GMP-regulated environments.
• At least 3 years of experience leading complex C&Q protocol development and execution.
• Experience qualifying aseptic-processing equipment, pharmaceutical isolators, restricted access barrier systems, Rapid Transfer Ports, or related systems.
• Hands-on experience with VHP cycle development, material transfer chamber qualification, steam autoclave PQ, or thermal mapping studies.
• Strong understanding of GMP, GDP, data integrity, risk-based qualification, and qualification lifecycle requirements.
• Experience with technical systems such as Ellab data loggers, thermal validation software, PLC/HMI controls, and electronic qualification platforms.
  
  
  

Responsibilities:

• Review project requirements and documentation to define qualification scope and strategy.
• Develop, review, and execute commissioning and qualification protocols for various systems.
• Lead VHP cycle development and qualification for isolators and material transfer chambers.
• Develop and execute autoclave performance qualification studies.
• Perform functional testing of equipment and controls under various conditions.
• Investigate qualification discrepancies and coordinate corrective actions.
• Prepare qualification reports and coordinate with cross-functional teams for project closeout.
  
  
  

If your background aligns with what we’re looking for, you may receive a call from Ava, our virtual recruiter, for a brief screening conversation. Ava will ask a few questions about your experience and interest in the opportunity.

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