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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

MSAT Validation Engineer


Reference:SMC3895 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 based with an award-winning biopharmaceutical organization in Cork. 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:

  • Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval
  • Review and approve documents prepared by other MSAT colleagues
  • Field execution of MSAT protocols
  • Liaise with Manufacturing to provide support where required with routine operations/project-based work
  • Compile relevant information from contractors, suppliers, and other departments to develop technical reports
  • Representing the MSAT site team on platform technical teams
  • Initiate and implement change control activities in accordance with site procedures
  • Track and resolve exceptions/events/deviations during MSAT activities
  • Prioritize MSAT activities in line with Manufacturing/project schedules
  • Co-ordinate MSAT activities with contractors and vendors as required
  • Attend identified training required to fulfil the role of a MSAT Engineer
  • Participate in multi-functional teams (project, investigations) as required
Education & Experience Requirements:
  • A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required
  • At least 2 yrs experience in the Large Molecule manufacturing industry or equivalent
  • Experience in Cleaning Validation studies and Cleaning Strategy (Minimum 2 years)
  • Also beneficial would be experience in Thermal Validation, Process Validation, Supporting Process Improvement Projects, Supporting New Product Introduction
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.