Biotech Validation Expert

3 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time

Life Science Recruitment is seeking a highly skilled Biotech Validation Expert to join an award-winning Pharmaceutical organization in Dublin. This is an excellent opportunity for a professional looking to work with a leading multinational company that excels in its field.

Duties
  • Oversee validation activities at External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation.
  • Audit and approve validation documents.
  • Ensure validated parameters are correctly incorporated in Master Batch Records.
  • Oversight of Aseptic processing system, including media fill, autoclave validation and EM content authorship.
  • Assess validation change control.
  • Perform Person in Plant activities as required.
  • Author applicable MA filing sections.
  • Write/review RTQs.
  • Prepare inspection playbooks.
  • Present on topics during inspection demonstrating appropriate behaviours and knowledge of the subject areas.
  • Drive Operational Excellence and Champion Change.
  • Determine validation strategy and outcome of validation activities.
  • Approve or reject validation documentation.

An ideal candidate will have a degree in science and/or engineering and 5+ years of experience in the biotech or pharmaceutical industry, with significant validation experience at Aseptic Manufacturing or API facilities.



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