Purpose
The Senior Process Engineer is responsible for introducing new processes and/or products (product transfer). Provide process engineering services in support of upgrade projects in an existing Sterile Filling Facility. Act as the Package Owner and Vendor Point of Contact for new process equipment and upgrades to existing process equipment. The Senior Process Engineer will work within cross functional teams to deliver a significant suite or multiple suites of related process scope.
Responsibilities
* Act as Package owner for new process equipment and upgrades to existing process equipment.
* Manage vendor(s) for critical equipment detailed design, fabrication, installation on site and delivery up to PQ completion.
* Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
* Facilitate team to complete process safety deliverables including PHA (Hazops).
* Work as part of a 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 consulted on key process suite activities.
* Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
* Support GES C&Q Lead to coordinate preparation and C&Q field execution.
* Develop and/or review system life cycle 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 system's post-OQ (PQ, PPQ) readiness.
* Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the MSD Manufacturing Network as required to support Project.
* The job-holder may also undertake Project Engineering duties including preparation of project related deliverables such as schedules, work plans, or equipment cost tracking.
Qualifications
* Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline.
* Minimum of 5 years post academic process engineering experience. Aseptic/sterile processing design, construction & start-up experience would be preferred.
* Demonstrated ability to lead / influence teams in matrix environment
* Excellent communication/presentation/organisational skills
* In depth understanding of process engineering and technologies pertinent to formulation and filling unit operations.
* Knowledge of SDLC methodology