Description
The successful candidate will be responsible for providing process, technical, and validation support including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification and validation as required. The role is based within the Technical Engineering function.Key Responsibilities:
Serve as technical support for manufacturing and new product introductions through.
• Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input by authoring/ reviewing /approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports,
• Execution/development of change controls
• Contribution to Kaizen events, as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc
• Implement subsequent corrective action through the change management system.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
Key Requirements:
• Minimum qualification B.Sc. or M.Sc./M.Eng Degree in Science, Chemical or Biopharmaceutical or equivalent discipline
• Proven experience in a cGMP biopharmaceutical processing/sterile filling design, start-up or manufacturing environment
• Excellent report / standard / policy writing skills; required
• Experience in process engineering and technologies pertinent to Formulation and Sterile Filling Operations including Media Prep, Buffer Prep, Adjuvant Manufacture, Formulation, Vial and Syringe filling and automated visual inspection; desirable
• Experience in both equipment and process validation experience; desirable
• Knowledge of the automation control platform; desirable
• Knowledge of FDA and EU regulations pertinent to aseptic processing, in particular, is desirable
• Report, standards, policy writing skills; required
• Lean Six Sigma and change control methodology experience; desired