Bioassay Specialist

1 week ago

Cork, Cork, Ireland beBeeBiotechnology Full time €70,000 - €100,000
Job Title

A Bioassay Specialist will support the operations team in line with safety, regulatory and organizational requirements.

  • This role is responsible for developing and modifying procedures to support manufacturing operations.
  • The ideal candidate will participate in process validations efforts and project implementations.

Responsibilities:

  1. Develop and modify procedures as needed to support the manufacturing operation.
  2. Participate in process validations efforts and projects implementations.
  3. Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
  4. Execute protocols in a timely basis to meet the project schedule requirements.
  5. Establish and lead the process for certification of technicians for visual inspection.
  6. Establish and maintain the defect library.
  7. Establish and execute the process for the trending of Visual Inspection Defects.
  8. Ensure all site visual inspection procedures are aligned with global guidance documents and regulatory requirements.
  9. Provide technical input to guide the development of SOPs for visual inspection.
  10. Leadership of manufacturing and validation activities during project life cycle.
  11. Coordination with internal external stakeholders for the evaluation of particles/defects.
  12. Support of technical transfers for future product introductions to the site.
  13. Investigate process exceptions or malfunction incidents affecting the process.
  14. Liaise with internal external engineering personnel and internal external quality personnel as required.
  15. Support the production team in ensuring that manufacturing processes are enabled and maintained to meet output and yield requirements.

Qualifications:

  • A relevant third level qualification in an engineering science or technical discipline.
  • At least three years of combined experience in technical operations quality or equivalent in a pharmaceutical healthcare organization.
  • At least three years of experience in the manufacturing environment of a biotechnology pharmaceutical or healthcare plant.
  • Previous experience in manufacturing processes of biotechnological drugs parenteral drugs solutions preparation fill finish lyophilisation sterilisation operations.
  • Experience in clean utilities desirable.

About this Job

This is a challenging role requiring strong technical skills leadership abilities and good communication skills.

Your Benefits

We offer competitive salary benefits and opportunities for career advancement.

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