Project Lead Pharma Manu Project Engineer TP

Description

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 the Engineering 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.

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.

Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword – it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.

Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Read Full Description