C&Q Engineer

C&Q Engineer (Westport)

Job Summary:

Role 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.

Requirements:



• BS Degree in engineering, science or technical discipline required.
• 3 years of Commissioning and Qualification experience, ideally working in 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 preferred. Familiarity with project management tools is advantageous.
• Previous experience with Clean Utility tie-ins to existing systems is desirable (i.e Upgrading existing purified water skid to support a new tank).
• Working knowledge of sanitary equipment, hygienic piping, process instrumentation and controls is desired Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.
• Adherence to cGMP and cGDP is mandatory. Strong technical writing skills are essential. The candidate must have a proven track record working within a fast paced GMP environment.
• The candidate must be able to work independently with limited supervision – self-sufficiency is critical. They must demonstrate strong interpersonal & teamwork skills. Must be flexible to support unexpected project demands and maintain the overall program schedule.