Role Summary: Provide project engineering services in support of the commissioning and qualification of a drug substance and drug product manufacturing facility.
The jobholder works within the Global Engineering Team to act as client representative to deliver integrated project engineering services to meet the Project Objectives.
The Project Engineer will assist in the management of cross functional teams to deliver a portfolio of assigned projects.
Job Responsibilities: Preparation of project related deliverables such as schedules, work plans, equipment cost tracking Coordination of project activities between stakeholders Manage installation / start-up / testing of key equipment systems through OQ completion.
Interface with cross-functional team to ensure systems post-OQ (PQ, PPQ) readiness.
Monitor costs and progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the Network as required to support Project.
Education/Experience Requirements: Minimum qualification B.Sc.
or M.Sc.
/ M. Eng Degree in Engineering.
Minimum of 6 years post academic engineering experience in relevant aseptic/sterile processing design and start-up environment.
Demonstrated ability to be a team player.
Excellent communication/presentation/organizational skills Notes: This is a contract position.
Estimated assignment duration is approx.
24 months, with initial 12 month contract.
The position is based fulltime onsite at the Dundalk Site The role may require small periods of travel to support vendor reviews.
Flexibility is required in this regard.
Skills: CQV OQ PQ PPQ