About the job

I am partnering with a multinatinal biopharmaceutical comapny that is looking to recruit a Validation Lead for their greenfield site in Tralee, Kerry. The validation lead will be responsible for leading the daily operations of the Validation function, managing Validation Engineers (staff and outsourced providers), coordinating activities, and improving operational efficiency. Responsibilities will also include ensuring 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. The Validation Lead will provide strategic leadership across the validation lifecycle—planning, execution, review, approval, and maintenance—aligned with GMP, data integrity principles, and risk‑based methodologies and own the Site Validation Master Plan (VMP), champion cross‑functional governance, and drive continuous improvement to maintain a validated state.

Role and Responsibilities

• Lead and develop the Validation team; foster an engaged, psychologically safe, high‑performance culture aligned with company values.
• Ensure stable supply and delivery of departmental objectives; resolve issues, prioritise effectively, and drive continuous improvement via ambitious KPIs.
• Maintain compliance 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 partnerships; support business continuity, mitigate risks, and deputise for site leaders as required.

Required 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.