Job Summary
The Commissioning & Qualification Engineer will be responsible for the Generation, Execution and Approval of Qualification documents for Direct Impact Systems (Facility, Utility and Equipment) and the generation of Commissioning test documents for not direct systems.
Key Responsibilities:
* Generation, Execution and Approval of Qualification documents for Direct Impact Systems (Facility, Utility and Equipment)
* Generation of Commissioning test documents for not direct systems
Ideal Background:
* Degree in engineering, science or technical discipline required
* 3 years of Commissioning and Qualification experience, ideally working in medical device or pharmaceutical organization
* Mandatory requirements include clean utilities, hygienic piping, process instrumentation, controls and TOPs
* Familiarity with risk-based approach to commissioning and qualification preferred
* Familiarity with project management tools is advantageous
Main Requirements:
* Adherence to cGMP and cGDP mandatory
* Strong technical writing skills essential
* Proven track record working within a fast-paced GMP environment
Main Systems in Scope:
* WFI Distillation, Storage and Distribution
* Purified Water
* POU Coolers
* Partswasher
* Sterilization Autoclave
* VHP
* Freezers
* Facility qualification
About You:
* Able to work independently with limited supervision self-sufficiency critical
* Strong interpersonal & teamwork skills
* Flexible to support unexpected project demands and maintain overall program schedule
Languages:
* English
Categories:
* Clean Utilities Commissioning
* TOPS