Project Lead Engineer
Location: 100% onsite in Tralee, Ireland.
Purpose & Scope
Plan, execute, and deliver engineering projects supporting biopharmaceutical manufacturing, facility upgrades, technology transfers, and process improvements.
Ensure projects meet safety, quality, regulatory and business requirements.
Coordinate cross‑functional teams and external vendors to ensure successful project delivery.
Role and Responsibilities
Lead end‑to‑end engineering projects including scopes, schedules, budgets, risks, handovers, and reporting.
Provide engineering expertise across equipment, utilities, automation, and process systems; develop URS/design documents; review drawings and FAT/SAT protocols.
Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and contractors; support design reviews, hazard assessments, and change controls.
Ensure GMP/GDP, FDA, EMA, ICH compliance; support commissioning, qualification, FAT/SAT and maintain audit‑ready documentation.
Prepare capital justifications, manage CAPEX budgets, track costs, and support procurement and vendor negotiations.
Identify and mitigate project risks, manage documentation and tracking tools, evaluate outcomes and drive continuous improvement.
Required Qualifications
Strong knowledge of GMP, validation, and pharmaceutical manufacturing.
Proficiency in project management tools (e.g., MS Project, Primavera).
Excellent analytical, leadership, organisational and troubleshooting skills.
Proven capability managing multiple projects in a regulated environment.
Preferred Qualifications
Bachelor’s degree in Engineering or significant relevant experience.
Experience managing pharmaceutical engineering projects, equipment vendors, and cross‑functional teams.
Benefits
Astellas offers a comprehensive and competitive benefits package.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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