Validation Lead

About Astellas

Astellas is a worldwide biopharmaceutical company focused on translating cutting-edge science into meaningful outcomes for patients. Its work spans key therapy areas such as oncology, ophthalmology, urology, immunology, and women’s health. Through research and development, the company aims to advance new treatment options for conditions with significant unmet medical need.

The company is looking for people who are energized by fast-moving environments, welcome fresh thinking, and are comfortable making well-considered risks. Astellas values integrity, accountability, and a strong commitment to delivering real-world impact.

Role Overview

The Validation Lead will oversee the day-to-day running of the validation team in Tralee, Ireland. This is a fully onsite position. The role is responsible for coordinating validation engineers, including both internal staff and outsourced support, and for improving how the function operates.

The position ensures that facilities, utilities, equipment, computerized systems, production processes, cleaning activities, analytical methods, and aseptic operations consistently perform as intended so that biopharmaceutical products remain safe, effective, and compliant. It also provides leadership across the entire validation lifecycle, from planning and execution through review, approval, and ongoing maintenance, using GMP, data integrity, and risk-based approaches. The role owns the Site Validation Master Plan and helps strengthen site-wide governance while supporting continuous improvement.

Responsibilities

• Direct and develop the validation team while promoting a motivated, safe, and high-performing working culture that reflects Astellas values.
• Keep departmental objectives on track, remove blockers, set priorities effectively, and improve performance through challenging KPIs.
• Ensure adherence to GMP, GDP, safety, environmental, and governance expectations, with strong audit preparedness and data integrity practices.
• Support site and global strategy by delivering key projects on time and within budget, while planning for future capability and skill needs.
• Drive the introduction of new products, technologies, systems, and procedures, making sure changes are managed compliantly and knowledge is transferred effectively.
• Develop effective partnerships across functions and globally, support business continuity, reduce risk, and step in for site leaders when required.

Requirements

• A bachelor’s degree, or an equivalent qualification, in engineering or a scientific subject; relevant deep experience may also be accepted.
• Substantial experience in a comparable leadership role, with strong technical understanding and validation expertise; experience in cGMP start-up settings is an advantage.
• Demonstrated success in managing complex technical initiatives, supporting commissioning and maintenance of cGMP manufacturing operations, and handling several priorities at once.
• Strong planning and communication abilities, including verbal and written English, along with good interpersonal skills.
• Ability to work both independently and as part of a team, with openness to new ideas and approaches.

What You Can Expect

Join a globally connected life sciences organisation working with peers who are committed to improving patient outcomes. Contribute to therapies that make a difference for patients around the world, while working in an environment that encourages scientific progress and professional growth.

Values

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Equal Opportunity and Recruitment Safety

Astellas is an equal opportunity employer. All qualified candidates will be considered without regard to race, color, religion, sex, national origin, disability, veteran status, or any other legally protected characteristic.

Applicants should stay alert to recruitment fraud. Genuine communication from Astellas will come only from an official LinkedIn profile or a verified company email address. Suspicious profiles or messages should be reported through LinkedIn Help.