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May

Support Engineer, Process Engineering

Thermo Fisher Scientific - Brisbane Grove, NSW

Engineering
Source: uWorkin

JOB DESCRIPTION

Thermo Fisher Scientific’s Mission is to enable our customers to make the world healthier, cleaner and safer, and the global coronavirus (COVID-19) outbreak is a powerful reminder of the importance of that Mission. In fact, Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and ultimately helping in the development of new therapeutics and vaccines.

Job Title

Support Engineer - Process Engineering

Reports to: Site Manager, Manufacturing Sciences and Technology (MSAT), Biologics Brisbane

Position

Location: Brisbane, Australia

Direct Reports: N/A

How You'll Make An Impact

The network of Patheon’s drug substance manufacturing sites includes St. Louis, USA, Groningen, Netherlands and Brisbane, Australia. The performance of each manufacturing site is linked closely to the timely introduction of new projects, right first-time manufacturing, and the on time delivery of products to customers.

As a Support Engineer - PE you will be responsible for supporting the Process Engineers in the 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 enjoys working collaboratively with others within a fast-paced project execution environment.

What will you do?

  • Supporting Process Engineer with the successful introduction and execution of new customer projects (NPI’s)
  • Supporting to ensure that new processes and process improvements are successfully transferred from Process Development or an external customer to Operations
  • Actively engage in PPI improvement initiatives within the PE team and network
  • Lead hands on troubleshooting efforts and root cause investigations to resolve deviations related to the equipment, process or product
  • To provide direction to the development sites regarding the facility fit of new processes
  • To support late phase process validation programs
  • Identify improvements and share best manufacturing practices across the network
  • Technology transfer, facility fit and implementation of new production processes
  • Generate and review GMP documentation including Standard Operating Procedures (SOPs), Technical Transfer documents, Master Batch Records, Process Flow Diagrams, Risk Assessments and Bills of Materials
  • Implement new technology and equipment within the production facility
How will you get here?

Education
  • Tertiary degree in Science or Engineering (biology, biotechnology, biochemistry, chemistry)
Experience:
  • 3+ years of experience in a biopharmaceutical GMP manufacturing environment or a Process Development lab / pilot plant
  • Knowledge of process development, scale-up and cGMP manufacturing of protein-based pharmaceuticals
  • Experience with single-use equipment and the use of automated process equipment within a GMP environment
  • Experience with the scale up of purification unit operations including chromatography and all types of filtration
  • Trained in leading Tap Root investigations
  • Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
  • Experienced in participating 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
  • Proficient with computer (MS Office) and internet skills. Working knowledge of controlled documentation and data systems.
What’s in it for you?
  • A competitive salary and performance related bonus structure
  • Access to Thermo Fisher’s global University
  • Development opportunities as part of a rapidly growing global organisation