CQV Engineer

Dispensing Equipment including down flow booth, matcom stations, PTS powder systems

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.

Tumble mixer equipment including CIP SKID

• Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.
• 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).
• Previous experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs is advantageous.
• They must demonstrate strong interpersonal & teamwork skills.
• Working knowledge of sanitary equipment, hygienic piping, process instrumentation and controls is desired
• BS Degree in engineering, science or technical discipline required.
• 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.
• 3 years of Commissioning and Qualification experience, ideally working in OSD or pharmaceutical organization.
• Must be flexible to support unexpected project demands and maintain the overall program schedule.
• The candidate must be able to work independently with limited supervision – self-sufficiency is critical.
• Previous experience with clean utility tie-ins to existing systems is desirable.
• Familiarity with the risk-based approach to commissioning and qualification preferred.

Utilities – compressed air