Validation Lead (IE)

Biopharma Careers; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

Astellas is seeking a leader to guide the daily operations of the Validation function at our Tralee site in Ireland. You will manage Validation Engineers (staff and outsourced providers), drive efficiency, and ensure processes, systems, and equipment perform to the highest standards in a GMP environment.

Responsibilities include leading the Validation team, maintaining compliance with GMP/GDP, and contributing to global strategy while delivering strategic projects on time and within budget.

Qualifications

• Bachelor's degree in Engineering or a Scientific discipline is required.
• Proven leadership of validation teams and projects.
• Strong communication and cross-functional collaboration capabilities.

Responsibilities

• Lead and grow the Validation team, fostering a high‑performance culture.
• Ensure continuous supply and achievement of departmental objectives with KPI delivery.
• Maintain GMP, GDP, safety and data integrity; ensure audit readiness.
• Contribute to site/global strategy and timely execution of strategic projects.
• Lead deployment of new products, systems, and procedures with compliant change management.

Skills

Validation leadership

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Engineering or Scientific discipline

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.

WorkingEnvironment and Location

This position is 100% onsite in Tralee, Ireland.

AtAstellas we recognize the importance of work/life balance, and we are proudto 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

Lead the daily operations of the Validation function, managing Validation Engineers (staff and outsourced providers), coordinating activities, and improving operational efficiency.

Ensure facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning procedures, analytical methods, and aseptic operations perform as intended and reliably produce safe, effective, and compliant biopharmaceutical products.

Provide strategic leadership across the validation lifecycle, planning, execution, review, approval, and maintenance, alignedwith GMP, data integrity principles, and risk ‑ based methodologies. Own the Site Validation Master Plan (VMP), champion cross ‑ functional governance, and drive continuous improvement to maintain a validated state.

Role and Responsibilities

• Leadand develop theValidation team; foster an engaged, psychologically safe, high ‑ performance culture aligned with Astellas values.
• Ensure stablesupply and delivery of departmental objectives; resolve issues, prioritise effectively, and drive continuous improvement via ambitiousKPIs.
• Maintaincompliance with GMP, GDP, environmental safety, and governance requirements; ensure audit readiness and robust data integrity.
• Contribute to site and global strategy; deliver strategic projects on time and within budget while anticipating future trends and skill needs.
• Lead implementation of new products, technologies, systems, and procedures; ensure compliant change management and effective knowledge transfer.
• Build strong cross ‑ functional and global

Essential Qualifications

Bachelor’s degree (or equivalent) in an Engineering or Scientific discipline, or proven relevant in depth experience.

Preferred Qualifications

• Extensive experience in a similar role with strong technical competence and validation leadership capability (cGMP start ‑ up experience advantageous).
• Proven ability to progress complex technical projects, support commissioning/maintenance of cGMP manufacturing, and manage multiple priorities.
• Excellent organisational, interpersonal, verbal, and written communication skills; able to work independently and collaboratively; open to new ideas.

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.
• RelentlessInnovation: 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

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

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.