Validation Team Leader- 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 Validation Team Leader- CSV be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
The Validation Team Leader will generate and deliver validation documentation, strategies, operating procedures and validation project proposals in line with cGMP, industry best practice and Lonza policy.
- Manage the day-to-day work of your team, allocating resource to projects and routine validation work.
- Manage staff objectives, annual leave, absence and annual performance reviews.
- Review and approval of protocols, reports, deviations, CAPA, Out Of Specification (OOS) and Out Of Trend (OOT) investigations
- Contribute to providing schedules for projects and routine work and provide cost estimates when required.
- Help to define policies and procedures within Validation through detailed understanding of cGMP guidelines and regulations
- Support the generation of Validation policies in line with business needs and industry developments
- Input into scientific and business direction of the department
- Contribute to process/method improvements if required
- Troubleshoot technical issues
- Perform other duties as assigned/ required
What we need you to have:
- BSc Qualified
- Extensive industry experience within CSV.
- Knowledge of Regulatory and cGMP guidelines, manages quality records,(deviations, investigations, CAPAs and Change Control), offers training in multiple areas of expertise
- Background within CSV including: Cloud based CSV, working with Laboratory Systems and Corporate systems (LIMS/SAP)
- Ensuring necessary safety assessments are carried out for all work and maintaining a high standard of safety training, reducing risks and managing safety incidents if they occur.
- Proven ability to deliver multiple projects to timeline and within budget
- Ability to multitask and prioritise
- Experience of mentoring and developing others scientifically
- Experience of use and promotion of knowledge management best practices
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.