Cleaning Validation Expert

Cleaning Validation 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 Validation Expert. In this role, you will be responsible for the cleaning validation related activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance.

Key responsibilities:

• Develop and coordinate equipment cleaning validation strategy and activities for the assigned projects in the Large-Scale Mammalian facility of Lonza Visp in collaboration with operations, QA/MSAT cleaning and QC.
• Prepare, organize and execute project specific cleaning validation related documentation (protocols, reports, annual cleaning review) according to Lonza procedures and in compliance with regulatory.
• Reviewing and approving cleaning related documents (QC studies, risk assessment, etc.)
• 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, technical changes and change requests
• Be the main counterpart of cleaning 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 80% of the time