CQV Engineer

Responsibilities

• Previous C&Q experience, Clean Utility Qualification experience mandatory
• Can work independently
• Works with a sense of urgency
• Organized
• Flexible to support project needs

• 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.
• BS Degree in engineering, science or technical discipline required.
• Min 3 years of Commissioning and Qualification experience, ideally working in OSD or pharmaceutical organization.
• Previous experience with Clean Utility tie-ins to existing systems is desirable.
• Previous experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs 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.