Senior Process Engineer Purpose Provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility.
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.
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.
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.
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.
Qualifications 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. #J-18808-Ljbffr