CQV Engineer

Team Horizon is seeking a CQV Engineer for a leading pharmaceutical company in Cork.

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.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

• You enjoy working on exciting projects and want to work with a global manufacturing site in Cork.

   

What you will be doing:

• 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.
   
• 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.

• BS Degree in engineering, science or technical discipline required.

• 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.
   
• 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).
   
• Facility/Qualification Dispensing Equipment including down flow booth, matcom stations, PTS powder systems Tumble mixer equipment including CIP SKID Utilities – compressed air

Candidate must be eligible to work in the EU