Manager, Msat Process Validation

vor 5 Monaten

Visp, Schweiz Lonza Vollzeit

Switzerland, VispToday, 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.

Key responsibilities:

- Responsible for a sub-team of process validation specialists within the MSAT validation group, reporting to the Head of MSAT Process Validation. The manager is responsible for the team development, resource management and tracking of all deliverables assigned to the team
- Defining the validation strategy for a specific project and implementing in accordance with Lonza GMP guideline
- Issuing process validation / study protocols and reports (incl. hold time studies and leachable & extractable studies) and ensuring that internal / external GMP standards and regulatory requirements related to process validations are adhered to in projects
- Assessing validation data for conformance to protocol acceptance criteria and supporting the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures
- Being involved as Subject Matter Expert in the execution of Discrepancy Records and Change Requests
- Assisting the department in developing programs and SOPs to meet current industry standards, internal and external regulatory requirements
- Participating and support regulatory inspections and customer audits

Key requirements:

- Bachelor or Master in Chemistry, Biotechnology, Life Sciences or related field
- Significant experience in the GMP regulated pharmaceutical industry, preferable in a role within a MSAT or Quality and Compliance unit
- Experience in project management, preferable in MSAT, Quality and Compliance
- Knowledge in biotechnological manufacturing processes, validation approaches and risk management
- Experience in interaction with different stakeholders within an organization and with regulatory agencies (Swissmedic, FDA etc.) would be an advantage
- Fluency in English, German would be an advantage

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: R53127**:

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