Technical Specialist – 24‑Month Contract

About the role

The Technical Specialist joins Bimeda’s Technical Operations team in Cambridge, supporting the execution of strategic projects such as line transfers, batch scale changes, new product introductions and CMO technical transfer packages. The role ensures processes are scalable, standardized and audit‑ready across the growing global manufacturing network.

Key responsibilities

• Manage line transfers, batch scale changes and new product introductions on the sterile fill‑finish line.
• Develop CMO technical transfer packages and lead PLCM investigations for post‑launch failures.
• Update procedures, Master Batch Records and other documentation impacting critical processing parameters.
• Drive cross‑site knowledge transfer, standardization and digital quality initiatives using eQMS/MES systems.
• Provide project support for documentation, data analysis, yield improvement and IQ/OQ/PQ activities.

Required profile

• Minimum five years of experience in sterile manufacturing or fill‑finish within the pharmaceutical or biotech industry.
• University or college degree in an engineering or science discipline (preferred).
• Strong understanding of regulatory guidance and ability to incorporate requirements into project documentation.
• Proven project‑management skills and ability to work independently while meeting cost, quality and timeline targets.
• Excellent written and oral communication in English and effective interpersonal skills across sites.

Required skills

• Sterile and non‑sterile pharmaceutical manufacturing processes.
• Line transfer, batch scale change and new product introduction expertise.
• CMO technical transfer and PLCM investigation experience.
• Regulatory documentation (SOPs, MBRs, deviations, specifications).
• Statistical data analysis and design of experiments.
• IQ/OQ/PQ oversight.
• Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook).
• eQMS/MES systems, data trending and analytics.
• Lean and Six Sigma methodologies.