You help keep our biopharmaceutical plant clean and safe by leading cleaning validation activities. You make sure our equipment meets the highest quality and compliance standards. You work with different teams to improve how we clean and check our equipment.
Your tasks
- Develop and coordinate cleaning validation strategies and activities for projects in the Large-Scale Mammalian facility in Visp
- Work with operations, QA/MSAT cleaning, and QC teams
- Prepare, organize, and carry out cleaning validation documents like protocols, reports, and annual cleaning reviews
- Review and approve cleaning-related documents, including QC studies and risk assessments
- Review and approve project-specific cleaning validation documents, like clean/dirty hold time plans and reports
- Coordinate troubleshooting and support investigations of deviations, and approve deviation records
- Act as a Subject Matter Expert for non-conformity records, technical changes, and change requests
- Be the main contact for cleaning experts
- Act as cleaning expert during inspections by healthcare authorities and customer audits
What you bring
- Master's or PhD degree in biotechnology, life sciences, or related fields
- Some experience in biopharma cleaning or cleaning validation, preferably in mammalian manufacturing
- Experience in cGMP-regulated biopharmaceutical environments and good understanding of biologics manufacturing and cleaning regulations
- Experience managing complex projects, ideally in MSAT or Quality
- Able to handle multiple tasks and meet deadlines
- Exposure to process development, upstream/downstream processes, scale-up, or manufacturing (mammalian cell culture is a plus)
- Experience with regulatory agencies like Swissmedic or FDA is a plus
- Strong communication, technical writing, and stakeholder management skills
- Fluent in English (written and spoken); German is a plus
- Able to work on site in Visp 80% of the time
What we offer
- Chance to make a real difference by improving lives around the world
- Opportunities to own your career and grow
- Work in a team that values creativity, challenge, and solving complex problems
- Ethical and responsible work environment
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Über uns
Lonza is a global leader in life sciences with locations across three continents. We help improve lives by supporting businesses in healthcare and science. At Lonza, you can grow your career, work with talented people, and make a real impact on the world.
Das Team
You join the MSAT Validation team at the Large-Scale Mammalian facility in Visp. The team works together to ensure high quality and compliance in all cleaning processes. You collaborate with operations, QA, and QC experts.