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Biologics Operations Specialist

1 week ago

Sligo, Sligo, Ireland TN Ireland Full time
Job Description

The Biologics Operations Specialist will produce biologics product material as per organizational needs in line with all relevant compliance materials. This person will work as a team member to support biologics operations in pharma operations in line with all safety, regulatory, and organizational requirements.

Responsibilities:

  1. To be assigned to the daily production operations operating different equipment.
  2. Documentation of all activities in line with cGMP requirements.
  3. Efficiently operate all biologics processes minimizing material loss.
  4. Operate Fill Line, Autoclave, Equipment Washer, Headspace Analyzer, Bioreactors, Chromatography Columns, Filtration Systems, Equipment Cleaning and Sterilization, Equipment Pressure Tests, Equipment/Filters Integrity Tests, Water Baths, Isolators and Lyophiliser, Headspace Analyser, as applicable.
  5. Perform the sanitation and cleaning of all relevant equipment and areas.
  6. Perform final product visual inspection and product intermediary packaging, as applicable.
  7. Assemble and inspect equipment in the manufacturing area to confirm its operational status and perform all in-process testing methods.
  8. Monitor process alarms.
  9. Material receipt from warehouse, verifying all pertinent documentation and the transfer of final material to warehouse inventory.
  10. Perform process tests and participate in qualification and validation activities as required.
  11. Diagnose and resolve events or exceptions of production equipment and processes.
  12. Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation.
  13. Keep detailed records, manual or electronic, of the operations carried out during the work shift.
  14. Active participation in Factory Acceptance Testing, Site Acceptance Testing, and commissioning and qualification of equipment.
  15. Ensure successful external inspections, and Division and Corporate audits.
  16. Active participant in the development of batch records and electronic batch records for the site.
  17. And any other duties as assigned.