- Independently organise several unit operations in accordance with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
- Perform equipment testing and equipment troubleshooting related to technical skills of Bioprocess Scientist III.
- Review, revise and author manufacturing batch records and material reconciliation.
- Write and carry out validation protocols for which a Bioprocess Scientist technical skill is required.
- Adhere to Patheon Biologics cGMP Quality Management System and the EH&S requirements.
- As SME of a number of unit operation or equipment, train co-workers that are unfamiliar with the certain unit operation or handling of specific equipment, including approval of on-the-job training.
- Lead deviation investigations and change controls to streamline and improve internal processes.
- Propose and implement Corrective and Preventive Actions and support the closure of Deviation Reports and Change Controls as well as writing Minor Deviation Reports in a timely manner.
- Lead lean (OE) initiatives and continuous improvements.
- Identify and overcome practical problems, proposes a possible solution and communicates to the responsible person.
- Support Department functions, such as maintaining production suite, supplies, equipment, logbooks, and data in compliance with site SOPs and policies.
- Support the transfer and understanding of specific new technologies to the Operations department.
- Support and implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Assist in review and writes quality GMP documentation.
- Liaise with suppliers about issues of technical nature.
- Any reasonable additional tasks that might be required for day to day Operational activities.
- This role may require you to be on shift, on-call roster and work some scheduled weekends. Should this be a requirement of your position, you will be remunerated per the Company's policy
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USP Bioprocess Scientist III - Brisbane, Australia - Thermo Fisher Scientific
Description
:Independently operate USP unit operations and equipment (Single Use Bioreactors and associated control software, shake flask, Wave Bioreactors, clarification processes etc) within a GMP environment.
Minimum Requirements/Qualifications:
Qualifications & Experience:
Preferably tertiary education in science or engineering based field ( biopharmaceuticals manufacture, biotechnology, process technology).
Skills & Attributes:
USP – cell culture passaging, WAVE bioreactors, 50 L – 2000 L stirred tank bioreactors for fed-batch and perfusion process, cell banking and depth filtration.
Proven track record to thrive in a fast-paced and dynamic working environment.
Excellent oral and written communication skills, as well as interpersonal skills.
Other Important Information
The Thermo Fisher Scientific site in Brisbane manufactures many products for clinical trials and commercial applications. Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse. Given the high value of the products and intermediates the Bioprocess Scientist has to be capable of judging the possible impact of a situation on product quality, yield, EH&S and cGMP compliance.
Due to involvement in the timely execution of manufacturing processes, interpersonal and organisational skills and flexibility in working hours are required.
Other Job Requirements:
Adhere to EH&S processes and ensure a safe and healthy workplace environment. Work safely and only perform tasks if currently competent and / or authorized. Report hazardous conditions, hazardous actions, incidents and near-miss incidents. Participate in EH&S activities (such as inspections and risk assessments) as advised.
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