MSAT Cleaning Expert

MSAT Cleaning Expert

Lonza

Visp, Switzerland

As part of the MSAT (Manufacturing Science & Technology) Validation team of our Large-Scale Mammalian facility in Visp, we are looking for a Cleaning Expert. In this role, you will be responsible for the cleaning related activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance.

Key responsibilities:

• Develop and coordinate equipment cleaning activities for the assigned projects in the Large-Scale Mammalian facility of Lonza Visp in collaboration with operations, QA/MSAT cleaning validation and QC.
• Coordinate the development, validation and compliant implementation of validated cleaning methods in routine manufacturing in collaboration with process development (PD), manufacturing and QC.
• Prepare, organize and execute project specific cleaning related documentation (MAC Plan, cleaning risk analysis, etc.) according to Lonza procedures and in compliance with regulatory.
• Technical assessment of carryover for cleaning purposes.
• Reviewing and approving buffer cleaning validation plan and reports.
• Reviewing and approving of project specific cleaning validation documents (including clean/dirty hold time plan/reports, annual cleaning review of the facility).
• Coordinate troubleshooting and support investigations of deviations (and approve DR).
• Act as a Subject Matter Expert (SME) for non-conformity records and change requests.
• Be the main counterpart of validation experts.
• Act as cleaning SME during inspections by healthcare authorities and customer audits.

Key requirements:

• Master’s or PhD degree in biotechnology, life sciences, or related disciplines. 
• Some working experience in biopharma cleaning and/or cleaning validation (preferably in mammalian manufacturing process).
• Working experience in cGMP-regulated biopharmaceutical environment and good understanding of the biologics manufacturing process and associated cleaning regulatory requirements.
• Proven experience in managing complex projects, ideally in MSAT or Quality.
• Ability to manage multiple tasks and meet deadlines effectively.
• Exposure to process development, upstream/downstream processes, scale-up, and/or manufacturing (preferably mammalian cell culture) is an advantage.
• Experience engaging with regulatory agencies (Swissmedic, FDA, etc.) is an advantage.
• Excellent communication, technical writing, and stakeholder management skills.
• Fluency in English (written and spoken); German is an advantage.  
• Able to come on site in Visp 60% of the time.