Lyophilisation Lead Engineer
Core
Lead engineer for lyophilisation operations, ensuring efficient, compliant production of biopharmaceutical products.
Role type
Senior IC lyophilisation process engineer
Builds
Lyophilisation production runs and validated processes for oncology, ophthalmology, urology, immunology, and women's health therapies
Domain
Life sciences / Biopharmaceutical manufacturing
Required skills
Lyophilisation process development, cGMP compliance, deviation management, root cause analysis, Lean Six Sigma, SCADA/PAT systems, aseptic vial lyophilisation, CIP/SIP/FIT, process instrumentation, qualification and validation
Preferred skills
Lyomax experience, advanced control systems expertise, project management, technology transfer
Technologies
SCADA, PAT, Lyomax, Lean Six Sigma
Responsibilities
Provide technical support to lyophilisation operations and control systems; Lead deviations, investigations, CAPAs, and root cause analysis; Manage projects, technology transfer, and commissioning; Train staff and maintain SOPs; Drive continuous improvement initiatives
Seniority
Senior, hands-on IC
