Project Lead Engineer (IE)

Biopharma Careers; Ireland; Hybrid; EUR 75,000 - 110,000; Full time

Job summary

Astellas is seeking a Project Engineer to plan, execute, and deliver engineering projects for biopharmaceutical manufacturing in Tralee, Ireland. You will coordinate cross-functional teams, ensure compliance, and drive continuous improvement across equipment and processes.

You will work in a hybrid setup with on-site collaboration and occasional remote work, contributing to safe, compliant and timely project delivery in a global life sciences environment.

Qualifications

• Strong knowledge of GMP, validation, and pharmaceutical manufacturing.
• Proficiency with project management tools such as MS Project and Primavera.
• Excellent analytical, leadership, organisational and troubleshooting skills.
• Proven track record managing multiple projects in a regulated environment.
• Engineering experience in an aseptic fill-finish clean room environment.

Responsibilities

• Lead end-to-end engineering projects including scope, schedule, budget, risks, handovers and reporting.
• Provide engineering expertise across equipment, utilities, automation and process systems; develop URS/design docs; 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.

Skills

GMP knowledge

Project management tools

Analytical leadership

Regulated environment experience

Aseptic fill finish experience

Education

Bachelor’s degree in Engineering or equivalent

Tools

MS Project

Primavera

Job description

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

This position is 100% onsite in Tralee, Ireland.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and 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 docs; 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.

Essential 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.
• Engineering experience in an Aseptic fill finish clean room environment

Preferred Qualifications

• Bachelor’s degree in Engineering or significant relevant experience.
• Experience managing pharmaceutical engineering projects, equipment vendors, and cross ‑ functional teams.

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

• Accountability
• Courage
• Impact
• Innovation
• Integrity
• One Astellas
• Outcome Focus
• Sense of Urgency
• Skills and Capabilities
• Organizational Focus

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.