Lead Biopharma Engineering Project Manager

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

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.