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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