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Job ID :
64718BR
Location :
Australia - Brisbane
:
Job Description
  • At least 4-5 years experience in USP including cell culture, single-use bioreactor (WAVE and SUB), single-use clarification, use of MFCS and cell banking in compliance with the relevant production protocols in a clean room environment under cGMP conditions.
  • Experienced in troubleshooting of fed-batch, perfusion and clarification processes as well as equipment troubleshooting.
  • Organised individual who is able to perform planning and scheduling as well as organising production suite, supplies, equipment and logbooks.
  • Support and implementation of new procedures and/or equipment in the OPS department
  • Review, revise and author manufacturing batch records, logbooks and material reconciliation.
  • As the SME of USP unit operation and equipment, training co-workers that are unfamiliar with certain unit operation or handling of specific equipment, including approval of on-the-job trainings.
  • Proposes and implements Corrective and Preventive Actions and support the on-time closure Deviation Reports and Change Controls
  • Being the lead investigator for Minor and Major Deviation Reports.
  • Pro-active in implementation of lean (OE) initiatives and continuous improvements under minimal direction.
  • Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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