This is a 12 month contract with a view to extension
To provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. The job-holder works with the Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. They will manage package deliverables forming part of the scope for a Drug Product Fill Finish project and participate in cross functional teams to deliver on objectives. They will be responsible for discreet equipment packages that include GMP Parts washing, Sterilization Autoclave, VHP Material transfer systems, Sanitary Process Equipment and Single Use Formulation systems.
• Support GES Process Lead and GES Suite Team Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
• Lead package ownership for the agreed packages and facilitate cross-functional interactions to ensure project and site stakeholder inputs are reflected in vendor design deliverables.
• Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
• Monitor progress of package milestones with all team members and provide status reports to project Suite and Tiers.
• Act as client owner representative to self-execute critical deliverables and oversee other deliverable by an Architect & Engineering design firm.
• Own package technical deliverables including User Requirement Specifications, Equipment Specifications, PHA (HAZOP) Action.
• Ensure Global and Local engineering standards, procedures and practices are followed for packages.
• Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
• Manage vendor efforts for installation / start-up / testing of process systems through PQ completion.
• Liaise with SMEs at other sites within the Manufacturing Network as required to support Project.
• On occasion, the job-holder may also undertake Project Engineering duties including:
– preparation of project related deliverables such as schedules, work plans, equipment cost tracking
– coordination of project activities between stakeholders
• Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical, Mechanical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with the basic elements of chemical/mechanical/ biochemical engineering fundamentals as applied to sterile or aseptic manufacturing.
• Minimum of 6 years post academic process engineering experience.
• Awareness of sterile drug product unit operation and sterile support/formulation systems is preferred.
• Knowledge of Sterile Drug Product processes
• Knowledge of hygienic/sterile process system design
• Demonstrated ability to lead / influence teams in matrix environment
• Excellent communication/presentation/organizational skills
• Knowledge of PLC process control platforms and industry SDLC methodology
• Note – The role will require periods of travel to support vendor FATs.
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