Description
Project Lead Engineer, 23-month FTC
About Astellas
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity
The Project Lead Engineer is responsible for planning, executing, and delivering key projects that
support biopharmaceutical manufacturing, facility upgrades, technology transfers, and process
improvements. This role ensures that projects meet regulatory, safety, quality, and business
requirements while coordinating cross-functional teams and external vendors.
Responsibilities
* Project Management: Lead end-to-end engineering projects, develop scopes, schedules, budgets, risk assessments, and deliver controlled handovers and closeouts while presenting progress to stakeholders.
* Technical Leadership: Provide engineering expertise across equipment, utilities, automation, and process systems; develop URS/design documents; review drawings, FAT/SAT protocols, and support commissioning, qualification, and process optimization.
* Cross-Functional & Vendor Coordination: Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and external contractors/OEMs; facilitate design reviews, hazard assessments, change controls, and technical meetings.
* Compliance & Quality Assurance: Ensure all deliverables meet GMP/GDP, FDA, EMA, ICH, and internal standards; support IQ/OQ/PQ and FAT/SAT activities; maintain documentation for audits and regulatory needs; promote strong safety culture.
* Budgeting & Cost Control: Prepare capital justifications, manage CAPEX budgets, track expenditures, control change orders, and support procurement, vendor selection, and contract negotiations.
* Risk & Performance Management: Identify and mitigate project risks, maintain documentation and progress tracking tools, and evaluate project outcomes to drive continuous improvement.
* Essential Knowledge & Experience
* Strong knowledge of GMP, validation, and pharmaceutical manufacturing, with proficiency in project management tools (e.g., MS Project, Primavera) and strong analytical, organizational, and troubleshooting skills.
* Excellent leadership, communication, stakeholder management, and people-management abilities, with proven capability to manage multiple projects in a fast-paced, regulated setting.
Education
* Bachelor's degree in Engineering or related field, or significant experience managing pharmaceutical engineering projects, equipment vendors, and cross-functional teams in a GMP-regulated environment.
Additional Information
* This is a 23 month FTC - full-time position
* Position is based in Tralee – Ireland
* This position requires you to be 100% on site / in the office
* Willingness to undertake international travel
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.
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