This is a 12 month contract
To provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility. The job-holder works with the Process Engineering Team as a client owner representative to deliver Project Objectives.
• The Senior Process Engineer will manage cross functional teams to deliver the Equipment package design, factory acceptance testing, installation and commissioning. Packages may include Autoclave, COP/SOP skid, WFI storage and distribution, Downflow Booth, Glovebox modifications, wave rockers and miscellaneous ancillary equipment.
• Support GES Process Lead to implement a Process Design based on the scope of Process Requirements outlined in the project scope of work.
• Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q 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.
• Oversee C&Q progression by a partner firm.
• Ensure the Global and Cork site engineering standards, procedures and practices are followed.
• Support GES C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
• Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
• Manage 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.
• The job-holder will also undertake Project Engineering duties including:
– preparation of project related deliverables such as schedules, work plans, equipment cost tracking
– Coordination of project activities between stakeholder
• 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 biotechnology/bioprocessing.
• Minimum of 7 years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
• Demonstrated ability to lead / influence teams in matrix environment.
• Excellent communication/presentation/organizational skills.
• In depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine processing facility.
• Knowledge on the application of single use technologies.
• Knowledge of DCS/PLC process control platforms and industry SDLC methodology.
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