Job Title: Process Chemical Engineer
Department: Technical Services
Position Reports to: Technical Services Manager
Provide process science and engineering, manufacturing technology and validation support to the ongoing requirements of the Vaccines PPU, as well to support process tech transfer projects into site. Responsibility is to ensure that the appropriate equipment and process conditions are used to effect the desired process, ensure that the process is running as intended, that it is appropriately validated and run so as to maintain that validated state.
This role focuses on process monitoring and trouble-shooting, including leading process investigations, implementation of cost reduction projects, facility and equipment design, knowledge capture from donor sites, assisting in technology transfer execution including process trials on the bench or at scale in support of these project objectives and execution of final process validation studies and write-ups.
The job-holder works with the Technical Services Teams to deliver integrated technical services to meet the site business objectives. The role requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.
1. Carry out process monitoring of commercial processes and work to improve process capability where weaknesses are identified.
2. Lead major process investigations as requested and support the implementation of CAPAs.
3. Write product/process impact assessments in support of investigation closures, as requested.
4. Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site and provide leadership in the use of OE principles to optimise our technical and business processes.
5. Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site personnel.
6. Participate in Gap Analyses and Risk Assessments to support the tech transfers
7. Write Tech Transfer Documents.
8. Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC
9. Help maintain the process model/mass balance for the processes
10. Model the running of the facility with Operations – number of batches, scale of equipment, facility sizing and layout, etc
11. Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up at Grange Castle
12. Ensure the process automation meets the requirements of the process
13. Assist in the raising and execution of change controls for Technical Services
14. Provide process expertise for trouble-shooting and resolution of manufacturing process and technology issues.
15. Provide process engineering expertise to support from preliminary engineering through to the end of process validation and delivery of the facility to Operations.
16. Own the Process Flow Diagrams (PFDs).
17. Provide technical training on process and technology areas as required by the project.
18. Support Compliance Inspections and enquiries from Regulatory Agencies.
19. Develop and maintain productive links with process equipment & technology supplier and vendors.
20. Prepare and execute process and cleaning validation protocols.
1. Ideally 3-4 Years cGMP industrial experience, ideally covering Operations, Engineering, Projects and Validation within bioprocess manufacturing.
2. In depth understanding of process engineering including biotechnology, purification technology and unit operations, potential impact of equipment on biological molecules.
3. Experience working with automated control systems.
4. Experience with technology transfer and project engineering preferred.
5. Experience of process and cleaning validation execution preferred.
6. Experience of FDA and EU licensing and inspection.
7. Demonstrated aptitude for technical learning and problem solving.
Minimum qualification of a B. Sc. Degree in Engineering, Bioprocess Science, Biotechnology or equivalent with particular emphasis in Biochemical, Chemical or Mechanical discipline.