Commissioning and Qualification Engineer
Location: Cork, Ireland. 6-month contract with potential to extend, on behalf of our multinational biopharmaceutical client.
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 in an OSD or pharmaceutical organization.
Experience with clean utility tie-ins to existing systems is desirable.
Experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs is advantageous.
Familiarity with the risk-based approach to commissioning and qualification; familiarity with project management tools is advantageous.
Working knowledge of sanitary equipment, hygienic piping, process instrumentation and controls is desired.
Adherence to cGMP and cGDP is mandatory. Strong technical writing skills are essential. Proven experience working in a fast-paced GMP environment.
Ability to work independently with limited supervision and demonstrated strong interpersonal and teamwork skills.
Flexibility to support unexpected project demands and maintain the overall program schedule.
Facility/Qualification experience including dispensing equipment such as down flow booths, matcom stations, PTS powder systems; and Utilities – compressed air.
Seniority level
Mid-Senior level
Employment type
Contract
Industries
Pharmaceutical Manufacturing
Biotechnology Research
Medical Equipment Manufacturing
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