Biopharmaceutical Process Specialist

2 weeks ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time
Job Summary

As a Biopharmaceutical Process Specialist at Thermo Fisher Scientific, you will be responsible for providing meaningful accountability to the overall departmental responsibility for the production of biopharmaceutical solutions and process intermediates. This includes maintaining optimized operational areas, dispensing of raw materials, preparation of media and buffer solutions, manifold preparation and autoclaving, filter integrity testing, and working proactively to supply lead lean initiatives and continuous improvements.

Key Responsibilities
  • Perform equipment testing, troubleshooting, and complete validation protocols with developed skills of Bioprocess Scientist II.
  • Support the implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users, including support to changes (CRF).
  • Propose and implement Corrective and Preventive Actions and support the timely closure of Deviation Reports and Change Controls as well as writing Minor Deviation Reports.
  • Communicate with suppliers about issues of technical nature.
  • Perform all activities independently within the department, coherent with cGMP Quality System and the Patheon EH&S requirements.

Requirements
  • Tertiary education in science or engineering-based field (biopharmaceutical manufacture, biotechnology, process technology) or relevant proven experience.
  • Very good knowledge and working in cGMP environment.
  • Specific knowledge of relevant process unit operations and quality systems.
  • Strong organizational, scheduling, and planning skills.
  • Ability to work unsupervised.
  • Good communication, flexibility, reliability, and assertiveness.
  • Responsible and proactive.
  • Enforce OHS policies and procedures and ensure a safe and balanced workplace environment.
  • Enforce the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law.

What We Offer
  • Competitive compensation and benefits packages.
  • Opportunities for professional growth and development.

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