CSV Specialist

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 currently looking to recruit a CSV Specialist to join our Validation team in Slough.

As a CSV Specialist, you will be generating and executing a variety of validation documentation in line with GMP (Good Manufacturing Practice) involved with computer and computerized systems in our biopharmaceutical manufacturing plant.

In this role, you will be involved with both hands on and office based work, which involves access to equipment in manufacturing and laboratory areas. This will give you the opportunity to work within a large, complex organization with a wide range of exposure.  

Key responsibilities:

• Performing routine and project validation work related to computer, computerized equipment (automated systems) installed onsite and cloud based systems
• Preparing and executing validation assessments, plans, protocols and reports
• Working with the Team Leader to create work plans and project cost estimates
• Contributing towards supporting Deviation, CAPA, Out Of Specification (OOS) and Out Of Trend (OOT) investigations
• Troubleshooting technical issues
• Maintaining an up to date training profile
• Contributing to process/method improvements if required

Key requirements:

• Demonstrable experience working within validation, particularly within CSV discipline
• Relevant experience or education in Life Sciences
• Working knowledge of SCADA validation systems, and DCS systems
• Experience working on projects, and undertaking tasks such as regulatory audits, GAP analysis
• Knowledge of Regulatory and cGMP guidelines, ability to contribute to quality records (Deviations, Investigations, CAPA and Change Control)
• Strong data integrity, and ability to prioritise tasks
• Excellent communication skills, able to deal effectively with various stakeholders

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.

#LI-IG1