Senior CQV/Process Engineer
We are seeking an experienced Process Engineer to support the design and commissioning of a significant expansion of an existing vaccine manufacturing facility in Cork.
Job Responsibilities:
* Support the 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.
* Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the Network as required to support Project.
Requirements:
* Minimum qualification: B.Sc. or M.Sc./M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline.
* 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.