We are working with a leading biopharmaceutical manufacturer who are seeking an MSAT Bioprocess Engineer to support the technology transfer of biologics processes from development into GMP manufacturing. This role is central to ensuring smooth scale‑up, robust documentation, and ongoing process improvements within a compliant Quality Management System.
Key Responsibilities
- Lead the technology transfer of new and existing biologics processes into GMP manufacturing.
- Prepare, review, approve and issue GMP manufacturing documentation, including batch records.
- Define scale‑up criteria and develop process mass balances and flow diagrams.
- Specify large‑scale equipment and assess material suitability for GMP use.
- Generate quality documentation for raw materials and equipment.
- Work within the site Quality Management System, raising and managing change controls.
- Conduct and close investigations, deviations and CAPAs.
- Project‑manage the introduction of processes into manufacturing from end to end.
- Perform risk assessments aligned with ICH Q9 principles.
- Collaborate cross‑functionally with MSAT, Development, Manufacturing, QA, Supply Chain, Engineering and Project Management teams, as well as relevant external partners.
Essential Qualifications & Experience
- BSc (Hons) or equivalent in a Science or Engineering discipline.
- Strong organisational and stakeholder‑influencing skills.
- Demonstrated project management capability and ability to meet deadlines.
- Experience in process scale‑up/transfer and providing manufacturing support.
- Effective communication across all levels.
- Experience evaluating materials for process suitability and writing GMP batch records.
- Commercialisation and process validation.
- Process improvement and process mapping.
- Defining, sourcing and validating large‑scale bioprocessing equipment.
- Effective team working
- Clear communication
- High attention to detail
Why Join
You’ll play a pivotal role linking development and GMP operations, directly influencing manufacturability, compliance and the successful delivery of biologics processes- while working within a collaborative, growth‑focused environment. The company also offer an extensive benefits package.
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