Building your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others.
Our open and progressive culture is what makes us Astellas. It is a culture of doing good for others and contributing to a sustainable society.
Reporting directly to the Engineering Projects & Systems Lead, the Project Engineer is part of a team for CAPEX and non-CAPEX projects from initiation to handover with responsibility for Project Management, Good Engineering Practice (GEP), validation/qualification. Full responsibility for project cash flow if assigned a project budget.
Join us in this dynamic role and contribute to our team's success at Astellas. Apply now to be part of this exciting journey.
About This Job
- Carry out project planning - this will include setting goals and objectives, defining roles and producing project schedules.
- Manage projects - which includes coordinating the project to carry out assigned tasks.
- Carry out feasibility studies for project approval including senior leadership approval presentation material.
- Lead and motivate your project team from both internal and external Astellas organisation.
- Ensure Projects are handed over in a controlled manner to the Business Unit as per the project charter deliverables.
- Close the project - including evaluating successes and challenges to enhance learning for your next project.
- Lead the generation of lifecycle documentation for process equipment and associated systems (URS, FDS, FAT, SAT, IQ/OQ, Risk Assessments, procedures etc).
- Draft & review validation documentation and execute all validation activities relating to the project.
- To validate systems & processes in accordance with cGMP.
- Maintenance of MES controlled documents such as System Configuration Specification & System Description.
- Industry experience working as a project engineer/project manager/validation engineer in the pharma projects environment with a demonstrated record of on-time project performance to budget including management of equipment vendors.
- Experience of managing the financial performance of engineering projects.
- Experience of coordinating engineers on project teams at all levels along with cross-functional teams and external service providers.
- Understanding the typical project life cycle from concept through to qualification and has proven experience in these areas.
- Excellent time management and organisational skills - Must be well organised in approach to work and disciplined in the evaluation of priorities and reaction to it.
- Must be able to deliver in a fast-paced environment where there can be simultaneously many competing priorities.
- Logical and analytical problem-solving skills.
- Excellent communication skills, both oral and written along with an ability to communicate ideas, concepts, and projects clearly and positively.
Preferred Knowledge & Experience
- Direct experience in drug manufacturing.
- Experience in a cGMP start-up environment.
Additional Information
- 20% travel (domestic and International)
- This is a permanent role.
- Based at manufacturing plant Tralee.
- This role is onsite.
At Astellas, we can offer an inspiring place to work and a chance to make your mark in doing good for others.
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