Biopharmaceutical Process Specialist
2 weeks ago
Job Summary
We are seeking a highly skilled Biopharmaceutical Process Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing meaningful accountability to the overall departmental responsibility for the production of biopharmaceutical solutions and process intermediates.
Key Responsibilities
- Maintain optimised operational areas, dispensing of raw materials, preparation of media and buffer solutions, manifold preparation, and autoclaving.
- Work proactively to supply lead lean initiatives and continuous improvements, revising, assisting in review, and writing documentation such as SOPs and ACFs.
- 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, including support to changes (CRF).
- Propose and implement Corrective and Preventive Actions and support the timely closure of Deviation Reports and Change Controls.
- 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 a science or engineering-based field or relevant proven experience.
- Very good knowledge and working in a cGMP environment.
- Specific knowledge of relevant process unit operations and quality systems.
- Strong organisational, 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.
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