Job Title: Senior Process Engineer
Overview of Role:
The Process Engineer provides process development technical support to large molecule and small molecule drug product manufacturing on site as well as being part of the global Process Development organisation.
• Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for parenteral products.
• Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterisation, Tech Transfer and Validation. Supports commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Adopts a customer-centric interface with manufacturing, and all partner support functions, to provide robust and coordinated support to manufacturing.
• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualisations. Investigates to determine true root cause.
• Develops and characterises drug product processes and transfer technology to commercial drug product sites.
• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
• Identifies and implements operational opportunities for current and new sterile operations.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Be a link to manufacturing on key investigations as a process expert.
• Bachelor’s degree & 10 years of directly related experience
• Direct industrial experience in the field of lyophilisation, specifically related to cycle development, scale up & technology transfer, in-silico modelling & optimisation, commercial support, process monitoring and troubleshooting (i.e. product impact assessment of process excursions).
• 10 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transfer (to commercial DP sites) or Validation.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
For additional information or to submit your CV get in touch with Sarah : [email protected]