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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

MSAT Validation Engineer


Reference:SMC83954 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

We’re currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities:

  • Lead/Execute/Participate in Equipment and System Validation Lifecycle processes, Qualification (IQ/OQ/PQ), Revalidation, Requalification and Equipment Periodic Reviews, for Equipment and Systems.
  • Coordinate with and guide other departments or outside contractors/vendors to complete validation tasks.
  • Participate in CSV Validation Lifecycle processes, Qualification (RS/QAP/UAT etc), CSV Periodic Reviews, for Equipment and Systems.
  • Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
  • Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
  • Execute/Participate in change controls and other compliance related tasks e.g. non-conformances.
  • Support regulatory audits
  • Lead/Support Shipping Qualification and/or Cleaning Verification/Validation activities
  • Work on own initiative to maintain adherence to schedule of activities including run the business and project workloads.
  • Support, lead or guide others in CQV projects.

Education & Experience Requirements:
  • Degree in a Science or Engineering discipline.
  • Experience in a GMP environment essential.
  • Minimum 5 years’ experience in a similar role.
  • Demonstrated capability to deliver results RFT, in an FDA/HPRA Regulated production environment.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.