Work Schedule
12 hr shift/days

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

About us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

• Provides meaningful accountability to the overall departmental responsibility for the production of biopharmaceutical solutions and process intermediates, including maintaining optimised operational areas. Dispensing of raw materials, preparation of media and buffer solutions (multiple 1000 L batches per day), manifold preparation and autoclaving, filter integrity testing.
• Works proactively to supply lead lean (OE) initiatives and continuous improvements. Revises, assists in review and writes documentation such as SOPs and ACFs.
• Perform equipment testing, troubleshooting and complete validation protocols with developed skills of Bioprocess Scientist II. Supports 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 Deviation Reports and Change Controls as well as writing Minor Deviation Reports.
• A pro-active demeanor and personal initiative is encouraged to identify and overcome practical problems, proposes possible solution and communicates to the responsible person.
• Communicates with suppliers about issues of technical nature.
• All activities should be performed independently within the department coherent with cGMP Quality System and the Patheon EH&S requirements.
• Any reasonable additional tasks that might be required for day-to-day Operational activities.

• Tertiary education in science or engineering-based field (i.e. 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 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
• Your position may require you to participate in on call work. If you are on call you are required to be available for immediate return to work outside of your normal and regular work pattern. Should this be a requirement of your position, you will be remunerated per the Company's policy.