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Process Engineer – Clean Utilities
Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. The individual works within the Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. This will involve managing technical package deliverables for Clean Utilities package for a Drug Product Fill Finish project and participate in cross functional teams to deliver on objectives.
• Support Process Lead and Suite Team Lead to implement a Clean Utilities Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
• Lead technical package ownership for the Clean Utilities package and facilitate cross-functional interactions to ensure project and site stakeholder inputs are reflected in vendor design deliverables.
o Drive resolution of technical issues and escalate risks to the Process Lead and Suite Team Lead.
o Ensure all project stakeholders are informed and consulted on key clean utilities suite activities and decisions.
o Monitor progress of package technical milestones with all team members and provide status reports to project Suite, Process Lead and Tiers.
• Act as client owner representative to self-execute critical deliverables and oversee other deliverable by an Architect & Engineering design firm.
o Own package technical deliverables including User Requirement Specifications, Equipment Specifications, PHA (HAZOP) Action.
• Support C&Q Team with FATs/C&Q readiness with document preparation and field execution.
o Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
o Manage vendor efforts for installation / start-up / testing of process systems through PQ completion and startup.
• On occasion, the job-holder may also undertake Project Engineering duties including:
o preparation of project related deliverables such as schedules, work plans, equipment cost tracking
o coordination of project activities between stakeholders
Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline;
• Minimum of 6 years post academic process engineering experience.
• Experience in leading Clean Utility system design, including Water for Injection, Clean Steam, Clean Dry Compressed gasses.
• Knowledge of WFI and CS equipment and system design
• Knowledge of hygienic system design
• Awareness of sterile drug product unit operation and sterile support/formulation systems is preferred.
• Demonstrated ability to lead / influence teams in matrix environment
• Excellent communication/presentation/organizational skills
• Knowledge of PLC process control platforms and industry SDLC methodology