Today, Lonza is a global leader in life sciences operating across five 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.
The role:
As the Senior Validation Specialist, you will be the go-to person for Computer System Validation (CSV) in the validation department. Your main responsibilities include working with internal customers to meet schedules and ensure accurate CSV protocols.
Key responsibilities:
1. Ensure validation compliance is maintained following the site validation master plan.
2. Maintain compliance within the department by maintaining validation documentation.
3. Ensure all activities are carried out safely and align with site Safety standards.
4. Provide technical expertise to projects/ QMS and internal enquiries in a clear and timely manner.
5. Participate in Data integrity/ ERES assessments for computerised / computer systems on the Slough site.
6. Perform GAP analysis for Computerised / Computer systems and implement the necessary remediation actions.
7. Support the site in maintaining its compliance objectives through timely closure of CAPA, Deviations, change assessments and Change control tasks.
Key requirements:
1. BSc degree in science, IT, Electronic/Electrical Engineering, or Automation, or equivalent experience.
2. Knowledge of Regulatory and cGMP guidelines contributes to quality records (Deviations, Investigations, CAPA and Change Control).
3. Sets and consistently achieves critical metrics and challenging goals for him/herself (and the team).
4. Capability to craft qualification/validation plans that align with regulations and Lonza SOPs.
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.
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