Site Process & Cleaning Validation Lead
Mayo | Permanent
Our client, a global biopharmaceutical organisation, is seeking a Site Process & Cleaning Validation Lead to join their Technical Centre Leadership Team in Westport.
This is a senior leadership role with full ownership of process and cleaning validation across the site, supporting a diverse product portfolio including eyecare products, implants, and biologics. You will play a critical role in ensuring regulatory compliance, driving validation strategy, and developing high-performing teams in a complex, highly regulated manufacturing environment.
Key Responsibilities
- Lead and execute site validation master plans for process and cleaning validation.
- Own PPQ activities, including protocol development, risk assessments, data analysis, and technical transfers.
- Review and approve validation documentation, reports, and change controls.
- Partner cross-functionally with Manufacturing, Engineering, Quality, Regulatory Affairs, and Laboratories.
- Ensure compliance with cGMP and global regulatory requirements (FDA, EMA, ICH).
- Lead validation investigations, deviations, and CAPA management.
- Represent validation during internal and external audits and regulatory inspections.
- Track and report site metrics (QMS, EHS, ComplianceWire, etc.).
- Manage revalidation schedules, APR inputs, regulatory responses, and lab validation reviews.
- Lead, coach, and develop a team of validation professionals.
- Manage resourcing, recruitment, budgets, and succession planning.
- Drive continuous improvement through KPI management and preventative action plans.
What We're Looking For
- Bachelor's degree with 9+ years, Master's with 7+ years, or PhD with 5+ years in a scientific or engineering discipline.
- 7+ years' experience in pharmaceutical process and/or cleaning validation.
- Strong knowledge of cGMP, FDA, EMA, ICH Q7/Q8/Q9/Q10.
- Proven leadership experience in a cross-functional, regulated environment.
Why Apply?
This is a high-impact leadership role within a globally recognised pharmaceutical manufacturing site. You'll have real influence over validation strategy, regulatory readiness, and team development - while contributing directly to product quality and patient safety.
