Project Lead Pharma Manu Project Engineer TP

Project Lead Pharma Manu Project Engineer TP 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 theEngineering Projects & Systems Lead, the Project Lead Pharma Manu Project Engineer TP 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 assign 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. Essential Knowledge & Experience Proven 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. Highly effective people management skills - Experience of managing engineers at all levels along with cross functional teams and external service providers. Understands the typical project life cycle from concept through to qualification and has proven experience in these areas. Proven knowledge, appreciation, and experience of working in a strongly regulated GMP environment. 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 thrive in an environment where there can be simultaneously many number one priorities. Logical and analytical problem-solving skills (a solution provider rather than a problem provider). Excellent communication skills, both oral and written along with an ability to communicate ideas, concepts, and projects clearly and positively. Preferred Knowledge & Experience Ability to perform qualification validation activities in accordance with the AICL procedures & processes. Senior experience drafting & reviewing validation documentation and executing all validation activities relating to the project. Proven ability to validate systems & processes in accordance with cGMP. Additional information 20% travel (domestic and International) This is a permanent role. Based at manufacturing plant Tralee. This role is onsite.