Validation Manager

United Kingdom, Slough

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

We are seeking to hire a Validation Manager to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

This position has an important part to play within the team.  Reporting to the site Head of Validation, you’ll be responsible for all aspects of the day-to-day management and leadership of the Validation team comprising approximately 20 staff.  Your focus will be on maintaining a collaborative, coordinated, team-based approach to equipment, systems, cleaning and computer validation and ensuring that commitments agreed, both with business stakeholders and QA colleagues, are delivered in accordance with established timelines and within budget.  The overall goal: to ensure that the facility is maintained in a validated state.

Key responsibilities:

  • Leading, managing and developing the site Validation team, including performance management and resource planning
  • Providing day-to-day oversight of site validation activities, dealing with technical, planning and compliance issues and providing support for team members and key stakeholders to ensure the business is supported
  • Ensuring that work is planned and delivered on time and performance is managed, measured and reported appropriately
  • Forging strong relationships with customer and stakeholder groups, including QA, Manufacturing, Quality Control, Analytical Services, Engineering, Capital Projects Team, Product Development, Project and Program Management, business services and maintenance departments
  • Reviewing/approving validation documents as appropriate
  • Developing and implementing a risk based approach to validation, updating policies in line with current regulations and industry standards, and continuously challenging and improving working practices and performance
  • Providing support and input for site projects and initiatives and ensuring that the Validation team are aligned
  • Managing change in alignment with business objectives. Supporting and coaching the Validation team through change to ensure positive outcomes

What we need you to have:

  • Bachelors degree (or equivalent) in a relevant science or engineering discipline
  • Experience managing and delivering all validation life-cycle elements for systems, equipment, computers and cleaning validation within a biopharmaceutical GMP manufacturing environment
  • Experience within multiple leadership roles with responsibility for leading teams through change, ideally within a CMO environment
  • Demonstrated competence in managing change and continuous improvement
  • Comprehensive appreciation of Pharmaceutical Quality Systems
  • Excellent communication skills, able to articulate complex information with internal customers and supporting functions such as QC, QA, Engineering and Operations and understand their concepts and concerns
  • Agility; able to act on information and data presented and make decisions aligned with business need, whilst remaining customer and compliance focused
  • Leadership ability; able to inspire and engage the Validation team and other key stakeholders
  • Excellent attention to detail and accuracy - a Quality mindset – and a commitment to delivering high standards
  • Team player; works well in local and wider team environment.
  • Time management; able to prioritise work and deliver projects on time and ensure critical deadlines met

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.  

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R33308