Process Engineer/Scientist, MSAT, Fill Finish
- Experience Level
- Experienced (non-manager)
Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.
Oxford Biomedica’s Manufacturing, Science and Technology Team is responsible for process and technology development activities from early concept through to product registration for market approval, to ensure that OXB’s new and existing manufacturing processes can deliver the productivity, performance, quality and cost benefits required in line with regulatory guidance.
We are currently recruiting for a Process Engineer or Scientist to join the team working within our Fill Finish sub team. One of the main purposes of this role is plan, execute and report completion of MSAT-related projects or tasks in alignment with department objectives.
Your responsibilities in this role would be:
- The delivery of assigned technical projects/tasks working directly with Manager to ensure project time lines are met according to internal and/or customer needs
- Trouble shooting identification and problem solving in the plant for process and quality issues of existing processes
- Supporting the implementation of new processes/products into OXB facilities and third party CMOs
- Supports improvement projects to achieve increased productivity improvement, quality and reliability improvements
- Analyses batch records and quality results and monitor consistency of operations by using appropriate database and statistical tools; propose and implement corrective actions
- Work will be conducted in compliance with OXB’s Quality, Safety and Environmental systems and procedures
To be successful in this role, you will have the following skills and experience:
- Degree or equivalent experience in Chemical or Biochemical Engineering with an appropriate level of relevant experience.
- Expertise in bioprocess design, scale-up and commercialisation
- Knowledge of GMP manufacturing and OXB processes including quality and regulatory requirements
- Understands the health, safety and environmental aspects of the work carried out
- Knowledge and relevant experience in the scale up and industrialisation of GMP manufacturing bioprocesses
- Understanding of quality management systems, environmental, health and safety aspects of the work and regulatory requirements
- Experience of using statistical data analysis tools such as JMP® and/or Minitab® is desirable
- Understanding of process hazard analysis (PHA) methodologies such as FMEA, HAZOP and HACCP would be desirable
Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team-work, and so can you. Collaborate. Contribute. Change lives
No agencies please.