Process Engineer (USP)
Thermo Fisher Scientific
- Brisbane, QLD
- Permanent
- Full-time
- The Process Engineer is an authority in their field and is regarded as such within and outside Patheon Biologics.
- As a member of the USP PE team, you will have the opportunity to learn our successful new product introduction (NPI) and technology transfer processes supported by our global partners and standards.
- You will support our customers through insightful client communications throughout the tech transfer and upstream processing steps.
- You will ensure that new cell generation processes and process improvements are optimally transferred from Process Development.
- Become an authority in mammalian cell culture including fed batch and perfusion culture.
- Coordinate mammalian cell culture processes for the production and manufacturing of recombinant proteins (including mAbs).
- Support the technical transfer assessment of facility fit, bioreactor processes, media, cell culture scale-up, and clarification (harvest) with support from the wider Manufacturing Sciences (MSAT) team.
- Lead hands on problem solving efforts and root cause investigations to resolve deviations related to the equipment, process, or product.
- Present process data and project updates to clients.
- Prepare protocols, reports, process flow diagrams, and manufacturing batch records, including the evaluation and interpretation of technical batch data.
- Provide onsite technical support for manufacturing scale processes across the Patheon network.
- Demonstrate a strong focus on continuous improvement. Help identify workflow, resource, or process gaps and complete improvement projects.
- Tertiary degree in Science or Engineering (biology, biotechnology, biochemistry, chemistry)
- Upstream bioprocessing experience using mammalian cell cultures preferred.
- Knowledge of FDA/EMA regulatory requirements applicable to biologics is preferred.
- Ability to apply GMP regulations and other international guidelines to all aspects of the position
- Strong MS Excel, PowerPoint and Word skills.
- Excellent problem solving and critical thinking skills, including strong attention to detail.
- Excellent writing, communication and presentation skills.
- Ability to analyze and summarize complex scientific data.
- Excellent organization, planning, and time management skills.
- Self-motivated, willing to learn, independent and a proactive driving force of efficient execution.
- Ability to work constructively on a team and adaptable to function in a changing environment
- Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
- 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.