Associate Director Validation - Biologics

Posted 08 July 2024
Salary€100000 - €110000 per annum + Bonus, Pension, Health
Job type Permanent
DisciplineEngineering Leaders and Specialists, Life Sciences & Engineering Technologies
ContactMelissa Caramante

Job description

This global healthcare company is committed to improving the health and well-being of people worldwide by developing, producing, and providing innovative healthcare services and solutions in more than 110 countries globally. With more than 20,000 employees in 30 countries worldwide, this biopharmaceutical leader improves the lives of patients suffering from many chronic, rare, prevalent and sometimes life-threatening diseases.

With a significant R&D pipeline and a diverse commercialised product portfolio in therapy areas such as immunology, hepatology, and intensive care to name but a few, this organisation has increased year on year its investment in Ireland, in addition to the widened scope of roles positioned at its operation in Dublin, which is a state-of-the-art biologics manufacturing plant and one of the premier sites in Dublin. With its continued expansion in Ireland and internationally, a need has arisen in the organisation for an Associate Director of Validation to lead all validation operations at this growing site, at an opportune time to join the business.

The Position

  • Responsible for overseeing validation schedule planning, test equipment purchasing and maintenance, as well as ensuring the upkeep and availability of all packaging and processing equipment, warehousing and associated facilities at our Dublin facilities through routine and regular qualification testing and reporting.
  • Develop, execute, and implement global validation strategies and management practices for continuous improvement to achieve the highest level of internal and external customer satisfaction, while minimizing operational expenses, capital investment and risk using modern validation practices.
  • Develop, implement, and maintain a performance dashboard and forum (Validation Council) that includes metrics to identify operational performance, functional goals, key site projects and opportunities for improvement, and be able to provide progress reports to executive management, in support of day-to-day and strategic activities.
  • Oversee the day-to-day operations of the validation group, evaluating performance towards the achievement of validation, production and packaging goals while maintaining worldwide regulatory compliance and minimizing errors.

The Person

  • Bachelor's degree in mechanical, Chemical Engineering, Manufacturing Engineering, Validation or Operations Management, Material Science or closely related scientific/technical discipline or qualification.
  • A minimum of 10 years GMP/GDP experience in a pharmaceutical/biologics environment.
  • Expertise in validation practices, philosophies and knowledge of cost drivers for plasma and plasma derivatives facility qualification and upkeep.
  • Ideally a strong knowledge of aseptic filling processes.
  • Previous experience in leading/managing teams.

To learn more about this role apply online or contact Melissa Caramante at HRM Search Partners on + 353 876923026 for a confidential discussion.