Project Lead Pharma Manu Project Engineer

Project Lead Pharma Manu Project Engineer

(Full-Time)

Reporting to the Lead of the Engineering Technology Group, the Project Lead Pharma Manu Project Engineer KP is a full-time role, which you will lead the planning, execution, and handover of pivotal projects within Astellas Ireland Killorglin Plant. Astellas are seeking a seasoned professional who thrives on delivering excellence within defined timelines, scope, and budget constraints while adhering rigorously to industry regulations.

Key Responsibilities:

• Feasibility Studies: Assess the practicality and viability of a proposed project or business case.
• Strategic Project Planning: Develop comprehensive project plans, defining clear goals, roles, and timelines to ensure alignment with organisational objectives.
• Efficient Project Management: Coordinate project activities, oversee task execution, and implement robust monitoring and control mechanisms to track progress and mitigate risks effectively.
• Transparent Reporting: Provide regular, transparent updates on project status to both management and the project team, facilitating informed decision-making.
• Equipment and System Oversight: Supervise the design, installation, and testing phases of new equipment and systems, ensuring seamless integration and functionality. This would include domestic & international travel as required.
• Handover: Facilitate the controlled handover of completed projects to Business Unit’s in accordance with predefined deliverables outlined in the associated project charter.
• Regulatory Compliance: Ensure strict adherence to pharmaceutical industry regulations, encompassing cGMP and FDA guidelines, throughout the project lifecycle.
• Documentation Leadership: Lead the generation of comprehensive lifecycle documentation for process equipment and associated systems, including URS, FDS, FAT, SAT, IQ/OQ, Risk Assessments, and PV.
• Safety and Quality Assurance: Uphold a culture of safety and compliance with cGMP guidelines and SOPs, fostering excellence in the execution of capital projects.
• Validation Expertise: Oversee projects qualification validation activities in alignment with AICL (KP) procedures and processes, ensuring accurate validation documentation.

Skills and Experience Required:

• Educational Background: Diploma/bachelor’s degree in engineering/technology or related field is mandatory.
• Professional Experience: A minimum of 7 years’ experience in Project Engineering or Project Management within the Pharma or Medical device projects environment is required, including introduction of new products & technology.
• Cross-functional Collaboration: Ability to collaborate effectively within cross-functional & global Astellas teams and with external service providers.
• Lifecycle Proficiency: Understanding of the typical project lifecycle from concept through to qualification, with demonstrated experience in these domains.
• Regulatory Acumen: Proven knowledge, appreciation, and hands-on experience working in strongly regulated GMP environments.
• Organisational Skills: Excellent time management and organisational abilities are essential for success in this role.
• Communication Skills: Superior communication and interpersonal skills are vital for effective collaboration and stakeholder management.

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.