- 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.
- The Process Engineer will assist in the management cross functional teams to deliver a significant suite or multiple suites of related process scope.
- The Senior Project Engineer/Manager will be required to collaborate and facilitate running of all activities to ensure the effective and efficient on-time delivery of these projects within the department.
- Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
- Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
- Ensure all project stakeholders are informed and consulted on key process suite activities and decisions. Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Support the Architect & Engineering design firm to:
- Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
- Support process safety deliverables including PHA (Hazops).
- Ensure site engineering standards, procedures and practices are followed in the design development.
- Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution
- Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
- Support installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
- Liaise with stakeholders, equipment vendors, business partners, and 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 or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to sterile or aseptic manufacturing.
- Minimum of 3 years post academic process engineering experience in relevant aseptic/sterile processing design, construction & start-up environment.
- Excellent communication/presentation/organizational skills
- Understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, E-Beam, Isolated Filling, Capping, Bioburden reduction/Sterile Filtration, and CIP/SIP is an advantage
- Knowledge of PLC process control platforms and industry SDLC methodology
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100