CQV Engineer New - Cork

Company Profile:

The company consistently scores high in Great Place to Work and top workplace lists thanks to its positive and inclusive culture.

It has also seen sizeable investment in recent time underlying their continued commitment to the surrounding area.

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.

Key Responsibilities:

• Coordinate and execute C&Q activities
• Develop the master list of C&Q test documents and activities.
• Generate C&Q summary reports.
• Ensure the C&Q schedule is developed and maintained.
• Generate all C&Q test documents (C&Q Plan/FAT/SAT/IV/FT/C&Q)
• Attend C&Q coordination meetings.
• Execute running the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
• Involve in tracking and reporting of C&Q status and risks/issues
• Ensures startup of equipment/utilities is completed in a safe and coordinated manner.
• Understand and apply industry specific compliance standards/ regulations to all CQV activities.
• Participate in root cause analysis and investigations.
• Proactively highlight any issues around compliance.
• Participate in internal and external audits and inspections where required

Requirements:

• 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).
• 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.

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