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Process engineer

Thermo Fisher Scientific Posted: 12/10/2021
Location: Canberra, New South Wales, Australia Type:  N/A
Disciplines:  Process Engineering
Remuneration: 
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When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Job Title: Process Engineer

Location: Brisbane

Reporting To: Manager, Operations and Process Engineering
At the Brisbane Pharma Services Group (PSG) Biologics site, we are a contract manufacturing organization (CMO) specialising in the production of biopharmaceuticals from mammalian cell culture. We supply manufacturing services including limited process development and contract "good manufacturing practice" (cGMP) grade drug substance to customers around the globe. These state-of-the-art medicines help cure cancer, rheumatoid arthritis, wet amacular degeneration and other chronic and acute diseases

How will you make an impact?
As a Process Engineer you will be responsible for successful transfer and implementation of new projects, driving harmonization of industry best practices, assisting with corporate projects, and major site related deviations/problems. The successful candidate will be a highly motivated self-starter who is able to assimilate new information quickly and who enjoys working collaboratively with others within a fast-paced project execution environment.

Key Responsibilities but not limited to:
  • Successful introduction and execution of new customer projects (NPI's), including designing experiments, researching new methods and designing laboratory and process reports for NPI
  • Ensure that new cell generation processes and process improvements are successfully transferred from Process Development for cell generation or an external customer to Operations
  • Support and lead teams with growing large-scale molecules, including studying the growth and characteristics of the living cells
  • Support customers with manufacturing living cells and investigate the chemical structure of the cells to support their scientific projects
  • Actively engage in Practice Process Improvement improvement initiatives within the Process Engineer team, and Manufacturing Sciences team
  • To provide onsite technical support for manufacturing scale processes across the Patheon network
  • Lead hands on troubleshooting efforts and root cause investigations to resolve deviations related to the equipment, process or product
  • Lead hands on troubleshooting efforts and root cause investigations to resolve deviations related to the equipment, process or product
  • Communicate the outcome of any investigation to internal and external customers
  • Support with cell technology transfer, facility fit and implementation of new production processes for customer projects
  • Generate, review and approve GMP documentation including Standard Operating Procedures (SOPs), Technical Transfer documents, Master Batch Records, Process Flow Diagrams, Risk Assessments and Bills of Materials

How will you get here?

Education
  • Tertiary degree in Science or Engineering (biology, biotechnology, biochemistry, chemistry)

Experience, Knowledge, Skills & Abilities
  • 3+ years of experience in a biopharmaceutical GMP manufacturing environment or a Process Development lab / pilot plant
  • Trained and experience in leading Tap Root investigations is preferred
  • Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment.
  • Ability to work in a matrix management system and influence and negotiate collaboratively with others without direct authority
  • Experienced in participating and leading process improvement and PPI Kaizen projects.
  • Self-driven and results oriented
  • Knowledge of FDA/EMA regulatory requirements applicable to biologics. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
  • Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make key decisions.
  • Technical knowledge of biopharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable
  • Proficient with computer (MS Office) and internet skills. Working knowledge of controlled documentation and data systems.

What's in it for you?
  • Employee recognition programs
  • A competitive salary and performance related bonus structure
  • Exposure to market leading cutting-edge technologies.
  • Development opportunities as part of a rapidly growing global organization

This role is based in Brisbane so if you are looking at relocating, we would really like to see your application for this role.
At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner, and safer

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