11 Month Contracting Role, Onsite, 25% travel
Role Summary:
* 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 Engineering Team as a client owner representative to deliver Project Objectives.
* The Senior Process Engineer will manage cross functional teams to deliver the following scope:
* Equipment package design, factory acceptance testing, installation and commissioning.
* Packages may include Product Vessels, Single Use Mixers, Single Use UFDF skids & CIP/SIP skids.
Job Responsibilities:
* 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 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 stakeholders.
Education/Experience/Requirements:
* 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 elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing.
* Minimum of 8 years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
* Demonstrated ability to lead/influence teams in a matrix team 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/biologics processing facility.
* Knowledge on the application of single-use technologies.
* Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.
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