Project Engineer
Your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others. Are you ready to apply? Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
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), and validation/qualification. Full responsibility for project cash flow if assigned a project budget.
About This Job
1. Carry out project planning - this will include setting goals and objectives, defining roles, and producing project schedules.
2. Manage projects - which includes coordinating the project to carry out assigned tasks.
3. Carry out feasibility studies for project approval including senior leadership approval presentation material.
4. Lead and motivate your project team from both internal and external Astellas organisation.
5. Ensure Projects are handed over in a controlled manner to the Business Unit as per the project charter deliverables.
6. Close the project - including evaluating successes and challenges to enhance learning for your next project.
7. Lead the generation of lifecycle documentation for process equipment and associated systems (URS, FDS, FAT, SAT, IQ/OQ, Risk Assessments, procedures etc).
8. Draft & review validation documentation and execute all validation activities relating to the project.
9. To validate systems & processes in accordance with cGMP.
10. Maintenance of MES controlled documents such as System Configuration Specification & System Description.
Essential Knowledge & Experience
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 co-ordinating 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.
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