C&Q Engineer Role Cork

CQV Engineer

  • Posted Oct 31, 2023
  • Cork
  • Contract
  • BBBH4483

LSC have a great contract opportunity for a CQV Engineer to join a leading pharmaceutical company based in Cork If you have 3+ years' experience in CQV or a similar function in the medical device, pharmaceutical or related industry and are ready for your next challenge, this could be the perfect project for you! 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.
Education / Experience:
  • Technical qualification at third level or equivalent in Engineering.
  • 3-5 years' experience Engineering or Commissioning and Qualification Management in a pharmaceutical or a highly regulated environment
  • Technical qualification at third level or equivalent in Engineering.
  • Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
  • Strong understanding of a risk based approach to commissioning and qualification within pharmaceutical industry
  • Demonstrated strong communication skills in dealing with various stakeholders and vendors.
  • Extensive knowledge and demonstrated experience in commissioning and qualification for Pharmaceutical / Biotechnology projects Experience
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Sarah Ninan at +353 21 4771 329 if you have any more questions about this opportunity!

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
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