Process Engineer (USP)

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Thermo Fisher Scientific's Brisbane Drug Substance Division seeks a Process Engineer (USP) who will be an authority in mammalian cell culture and a key player in tech transfer and process scaling. You will coordinate upstream bioprocesses for recombinant proteins and mAbs, support facility fit assessments, lead root-cause investigations, and present process data to clients while driving continuous improvement across the Patheon network. The ideal candidate has a degree with GMP biotech experience, solid regulatory knowledge, and strong data analysis and communication skills. To apply, tailor your CV to quantify tech transfers and investigations, highlight collaboration and project leadership, and confirm onsite work, travel up to 20 percent, and occasional weekend coverage.

Work Schedule

Environmental Conditions

Job Description

As part of the Patheon / Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

About us

Brisbane / Drug Substance Division - One of the five divisions that make up the Pharma Services Group. At the Brisbane site we specialize in GMP clinical and commercial manufacturing of large molecule biologics including for clinical Phase I, II, and III, applying powerful single use bioreactors and biologics technologies. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally. The network of Patheon’s drug substance manufacturing sites includes St. Louis, USA, Groningen, Netherlands, Lengnau, and Brisbane, Australia.

Discover Impactful Work!

• 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.

A day in the Life:

• 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.

Experience

• 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

REQUIREMENTS:
• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in GMP-regulated pharmaceutical/biotech manufacturing
• Preferred Fields of Study: Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or related scientific field
• Strong technical expertise in process development, scale-up, and technology transfer
• Proven ability to lead complex investigations and implement effective solutions
• Experience with process validation and qualification activities
• Expert knowledge of cGMP regulations and quality systems
• Advanced project management and documentation skills
• Strong analytical and statistical analysis capabilities
• Excellent verbal and written communication skills
• Ability to work collaboratively in a matrix environment
• Proficiency with statistical analysis software and Microsoft Office suite
• Experience mentoring colleagues and providing technical training
• Strong problem-solving skills and attention to detail
• Ability to support manufacturing operations as needed, including some weekend/off-hours coverage
• Travel up to 20% may be required
• Foreign language skills may be required for some locations