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IT CSV Engineer (Pharma)

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Job Summary

  • Cork
  • Contract
  • JN -012024-1953703
  • Jan 10, 2024
  • Competitive
Job Description

My client is seeking a CSV Engineer who has IT/Infrastructure experience in the pharmaceutical industry for an hourly rate hybrid contract based in Cork.

Key Responsibilities

  • Ensure Regulatory compliance in area of responsibility (Annex 11/15, 21 CFR Part 11, GAMP 5) for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.).
  • Collaborate with iQMS and site teams to review and approve documentation.
  • Work in conjunction with Global IT Infrastructure teams and site teams to identify, create, review, and approve documentation.
  • Facilitate and coordinate resources for the identification, creation, review and approval of IT infrastructure documentation.
  • Contribute to a safe working environment by adhering to all pertinent environmental health/safety practice rules and regulations.

Qualifications and Skills

  • 3 + years' experience working with validation and qualification projects within GMP regulated environments.
  • Solid understanding and hands-on working knowledge of Computer Systems Validation requirements for all aspects of computer systems and infrastructure involved in medicinal product production.
  • Strong written and verbal communication skills.
  • Demonstrated ability to collaborate with cross-functional organisations in a dynamic manufacturing environment to solve problems.
  • Excellent interpersonal, communication (written and verbal) and time-management skills.
  • Strong trouble-shooting and problem-solving skills.
  • Logical thinking and a proactive mindset.
  • Critical thinking, creativity, collaboration and communication.
  • Detail-oriented with a commitment to maintaining the highest standards of compliance.
  • LEAN and Six Sigma philosophy are embedded in your day to day working.
  • Experience in the pharmaceutical industry.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Barry O'Mahony
Barry O'Mahony