Senior Validation Specialist

United Kingdom, Slough

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 currently looking for an experienced Senior Equipment Validation Specialist to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

Working as part of the Equipment Validation Team, this role involves generating and executing a variety of validation documentation in line with cGMP, industry best practice and Lonza policy to validate temperature controlled equipment, automated manufacturing systems, sterilization systems, SIP and CIP systems, utilities and HVAC equipment in a biopharmaceutical manufacturing plant.

This role provides a combination of hands-on and office based work and involves access to equipment in manufacturing, laboratory and warehouse areas.

Key responsibilities:

  • Perform routine and project validation work related to utilities, sterilization, biopharmaceutical manufacturing equipment (cell culture, downstream purification, filling and packaging) and controlled storage equipment installed on site.
  • Prepare and execute validation assessments, plans, protocols and reports.
  • Work with the Team Leader to create work plans and project cost estimates.
  • Contribute towards supporting Deviation, CAPA, Out Of Specification (OOS) and Out Of Trend (OOT) investigations.
  • Troubleshoot technical issues.
  • Maintain an up to date training profile.
  • Contribute to process/method improvements if required.
  • Perform other duties as assigned/required to support the objectives of the Validation Team

Key Requirement:

  • Degree (or equivalent) in a science or (related engineering) discipline
  • Extensive experience in a Validation role within the biopharmaceuticals industry.
  • Extensive experience within Equipment Validation
  • Knowledge of Regulatory and cGMP guidelines, contributes to quality records (Deviations, Investigations, CAPA and Change Control)
  • Ability to multitask and prioritise
  • Ability to effectively navigate and collaborate across multiple levels of the organization to achieve shared goals

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: R30963
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