Our client, a leading biopharmaceutical company based in Co.
Louth, is seeking a Project Engineer to support the commissioning and qualification of a new drug substance and drug product manufacturing facility.
The successful candidate will work as part of their Global Engineering team, acting as a client representative to deliver integrated project engineering services in alignment with project objectives.
The role will involve coordinating cross-functional teams and supporting the delivery of a portfolio of assigned projects within a GMP-regulated environment.
Responsibilities:
• Prepare key project deliverables, including schedules, work plans and equipment cost tracking.
• Coordinate project activities between internal and external stakeholders.
• Manage installation, start-up and testing of equipment systems through OQ completion.
• Interface with cross-functional teams to ensure systems are prepared for post-OQ activities, including PQ and PPQ readiness.
• Monitor project costs and progress, tracking process suite team milestones and preparing status updates for stakeholders and project tier meetings.
• Support cross-functional project teams to ensure stakeholder inputs and requirements are clearly defined and incorporated into design deliverables.
• Liaise with equipment vendors, business partners and SMEs across the wider network as required to support project delivery.
Qualifications & Experience:
• Bachelor's or Master's degree in Engineering (B.Sc., M.Sc. or M.Eng.).
• Minimum of 6 years' post-graduate engineering experience in an aseptic or sterile processing design and start-up environment.
• Demonstrated ability to work effectively as part of a team.
• Some travel may be required to support vendor reviews, and flexibility is expected.