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MSAT Process Validation Specialist
vor 3 Stunden
The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
In this position of MSAT Process Validation Specialist, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).
What you will get:
An agile career and dynamic working culture
A highly collaborative environment that fosters teamwork and inclusion
A range of professional development programs to grow your skills and career
An ethical workplace where tasks are carried out in accordance to the relevant procedures
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits in Visp:
What you will do:
Preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory guidance.
Leading the process validation teams including communication with customers.
Supporting PD teams during the process characterization phase. Reviewing and approving of process characterization documents.
Responsibility for the validation assessment on changes and deviations (approval of deviation and changes).
Preparation and maintenance of a documented continued process verification plan.
Authoring, assessing and approving of Product Quality Reviews.
What we are looking for:
Master or Ph.D in Chemistry, Biotechnology, Life Sciences or related field
Experience in project management, preferable in MSAT, Operation, Quality and Compliance.
Experience in interaction with different stakeholders within an organization and with regulatory agencies (Swissmedic, FDA etc.) would be an advantage.
Fluent communication in English (written and spoken), additional fluent communication in German is appreciated.
Ability to work on different tasks simultaneously and to work towards deadlines.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
