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Manufacturing Operations Specialist

1 month ago

Cork, Cork, Ireland RT Full time

Process Operations Specialist - with a flavour of Microbiology -

The Operations microbiologist is responsible for active participation in the microbiological control and assurance program within the operations department. This is not a QC Micro role.

This role will suit a Process Engineer/Specialist who may have a Biopharma qualification.

Role:

  1. Perform routine area walkdowns / GEMBA's.
  2. Support and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
  3. Perform Risk Assessments for operations projects and business innovation initiatives.
  4. Define specific aseptic techniques to be performed for crucial process steps.
  5. Support periodic review of environmental monitoring and in-process sampling trends and identify appropriate corrective and preventative actions as required.
  6. Provide effective and timely communication of any adverse trends or activities as appropriate.
  7. Achieve individual goals through actively working with departments and individuals.
  8. Maintain customer focus to deliver business requirements.
  9. Collaborate with Process Microbiologists internally.
  10. Access global microbiology support resources, as required.
  11. Review and approve relevant SOP's and WI's.
  12. Participate in the planning for future requirements in Operations.
  13. Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
  14. Participate in relevant internal and external manufacturing-related audits.
  15. Understand and support current regulatory trends and future testing requirements.
  16. Deputize for the Microbiology team, as required.
  17. Comply with EHS rules and procedures at all times.

ESSENTIAL:

  1. BSc in a scientific/technical discipline required, with Micro modules completed.
  2. 3-5 years of experience within a pharmaceutical or GMP regulated Operations environment.
  3. Possess knowledge and experience of the shop floor manufacturing process.
  4. Possess knowledge of data analytics.
  5. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

DESIRABLE:

  1. Validation experience within a Life Sciences or Biopharmaceutical manufacturing environment.
  2. Business Excellence and Problem Solving skills qualifications e.g. Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
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