C&Q Engineer (Westport)
Job Summary:
The role will be responsible for the generation, execution, and approval of qualification documents for direct impact systems (facility, utility, and equipment) as well as the creation of commissioning test documents for non-direct systems.
Key Requirements:
* BS degree in engineering, science, or technical discipline
* 3 years of commissioning and qualification experience, preferably in a medical device or pharmaceutical organization
* Previous experience with clean utilities, hygienic piping, process instrumentation, controls, and TOPs is mandatory
* Familiarity with the risk-based approach to commissioning and qualification is preferred
* Familiarity with project management tools is advantageous
* Previous experience with clean utility tie-ins to existing systems is desirable
Essential Skills:
* Adherence to cGMP and cGDP
* Strong technical writing skills
* Ability to work independently with limited supervision
* Strong interpersonal and teamwork skills
* Flexibility to support unexpected project demands
The ideal candidate must have a proven track record working within a fast-paced GMP environment. Self-sufficiency is critical in this role.