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 key member of the Biologics MSAT Department, this individual will be responsible for providing technical support to the Patheon Biologics global network.
As a Senior 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.
What will you do?
- Successful introduction and execution of new customer projects (NPI’s)
- Ensure that new processes and process improvements are successfully transferred from Process Development or an external customer to Operations
- Ensure delivery on all relevant key KPI’s for the BNE site and BIO network
- Actively engage in PPI improvement initiatives within the PE team and network
- 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
- Communicate the outcome of any investigation to internal and external customers
- 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, 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
- Implement new technology and equipment within the production facility
How will you get here?
- Tertiary degree in Science or Engineering (biology, biotechnology, biochemistry, chemistry)
- 7+ 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
- Ability to work in a matrix management system and influence and negotiate collaboratively with others without direct authority
- Experienced in participating and leading 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?
- 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