Commissioning & Qualification

This  C&Q Engineer role is focused on ensuring that facility, utility, and equipment systems meet regulatory and operational requirements. It is a highly regulated position that involves generating, executing, and approving qualification documents for direct impact systems (those affecting product quality, such as purified water and sterilization equipment) and commissioning test documents for non-direct systems (supporting systems that don’t directly impact product quality).

Key Responsibilities

• Qualification & Commissioning:

  • Develop, execute, and approve qualification documents (IQ/OQ/PQ) for facility, utility, and equipment systems.
  • Generate commissioning test documents for supporting systems.
  • Ensure systems comply with GMP and GDP.

• Systems in Scope:

  • Water Systems: WFI , Purified Water, POU  Coolers
  • Sterilization & Cleaning Equipment: Parts washers, sterilization autoclaves, VHP systems
  • Storage & Environmental Controls: Freezers, facility qualification activities

• Technical Expertise Required:

  • Clean utilities & hygienic piping – ensuring that systems like purified water and WFI meet strict sterility and contamination control standards.
  • Process instrumentation & controls – working with sensors, flow meters, pressure gauges, and automated control systems.
  • Risk-based approach – experience in risk assessments for commissioning and qualification activities.
  • Project management tools – useful for tracking and executing qualification and validation projects.

Ideal Candidate Profile:

• Engineering or science degree (BS level)
• At least 3 years of experience in commissioning & qualification within pharma or medical devices
• Strong technical writing skills for creating qualification documentation
• Hands-on experience with clean utility tie-ins (e.g., upgrading purified water systems)
• Ability to work independently, manage unexpected project demands, and collaborate in a fast-paced GMP environment

This role is critical in ensuring that manufacturing systems are properly commissioned and qualified to meet regulatory and quality standards, playing a key part in the production of pharmaceutical or medical device products.