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Msat bioprocess specialist

Falkirk
Permanent
SRG
Posted: 16h ago
Offer description

The Opportunity 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. Proven GMP biologics manufacturing or process development experience. St...

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