Senior Validation Specialist - CSV
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 for an experienced Senior Validation Specialist - Computer Systems Validation (CSV) to join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
As a Senior Validation Specialist - CSV you will be Working as part of the CSV Team, generating and executing a variety of validation documentation in line with cGMP, industry best practice and Lonza policy to validate computer and computerized systems in a biopharmaceutical manufacturing plant. This role provides a combination of hands-on and office based work and involves access to equipment in manufacturing and laboratory areas.
- Planning and performing routine and project validation work related to computer, computerized equipment (automated systems) installed onsite and cloud based systems to meet current GMP regulations and guidelines, industry best practice and company policy.
- Generating and executing validation project plans, protocols and reports.Formally reviewing validation protocols, reports and procedures generated by Lonza staff or external vendors.
- Work with the Team Leader to create work plans and project cost estimates.
- Processing and managing quality records including Deviation, CAPA, Out Of Specification (OOS) and Out Of Trend (OOT) investigations.
- Planning and reporting progress to the Team Leader and internal customers to ensure validation activities are aligned with QA, Quality Control, Manufacturing, Analytical Services, Manufacturing Science and Technology, Product Development and Engineering groups.
- Degree (or equivalent) in a science or (related engineering) discipline
- Knowledge of CFR 21 Part 11, GAMP 5 and Data Integrity
- Extensive experience in a Validation role within the biopharmaceuticals industry.
- IT knowledge (access control, account setup, file permission, database knowledge, cloud knowledge).
- Good understanding of validation principles and practices and a risk based approach
- Good appreciation of cGMP in biopharmaceutical manufacturing
- Experience with pharmaceutical Quality Systems including change control, deviation and CAPA.
- Knowledge and understanding of biopharmaceutical manufacturing operations (desirable)
- Good communicator, able to articulate complex information concisely and with sensitivity to the audience at hand and to build effective relationships with internal customers and supporting functions such as QC, QA, Engineering and Operations.
- Able to prioritise own activities to 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.