Job Title: Commissioning & Qualification Engineer
Duration: 9-month contract
We are seeking a skilled Commissioning & Qualification Engineer to join our team in Mayo. The ideal candidate will have a degree in engineering, science, or a technical discipline and a minimum of 3 years of experience in commissioning and qualification.
Main Responsibilities:
* Generate, execute, and approve qualification documents for Direct Impact Systems (Facility, Utility, and Equipment)
* Create commissioning test documents for non-direct systems
Ideal Background:
* Experience working in medical device or pharmaceutical organizations
* Familiarity with clean utilities, hygienic piping, process instrumentation, controls, and TOPs
* Risk-based approach to commissioning and qualification
* Project management tools
Requirements:
* cGMP and cGDP adherence
* Strong technical writing skills
* Proven track record working in a fast-paced GMP environment
* Independence with limited supervision
* Strong interpersonal and teamwork skills
Main Systems in Scope:
* WFI Distillation, Storage, and Distribution
* Purified Water
* POU Coolers
* Partswasher
* Sterilization Autoclave
* VHP
* Freezers
* Facility qualification
Key Skills:
* Clean utilities
* Commissioning
* TOPS