MSAT Bioconjugates Cleaning Validation Expert

MSAT Bioconjugates Cleaning Validation Expert

Lonza

Visp, Switzerland

In the position of MSAT BioConjugates Cleaning Validation Expert, you will make a difference by being responsible for the definition of cleaning validation strategies, cleaning validation documents and manufacturing support. Become part of this exciting opportunity and apply now! 

What you will Do:

• Serves as the owner of the overall cleaning validation strategy, with deep scientific and technical understanding of cleaning concepts, unit operations, historical documentation, and relevant asset, quality, analytical, and operational knowledge;
• Collaborates closely with QA Cleaning Validation, Operations, and other stakeholder departments to drive decisions related to changes, improvements, and validation impact assessments for both existing and new assets;
• Contributes to broader MSAT goals by working effectively with other MSAT functions to ensure alignment and successful project execution;
• Develops, defines, and designs the site’s cleaning validation strategy, ensuring scientific robustness and regulatory compliance;
• Leads cleaning validation campaign preparation, including authoring protocols and reviewing key documents such as FMEAs, QC cleaning studies, execution protocols, validation master plans, and change‑related assessments;
• Supports campaign execution and finalization by assessing deviations and investigations, evaluating data against acceptance criteria, defining corrective actions, supporting batch release, and determining the need for additional validation activities;
• Owns and manages all cleaning‑validation‑related documentation (e.g., SOPs, protocols, reports, annual reviews), maintains the cleaning validation matrix to ensure an overview of the manufacturing facilities and products, monitors evolving regulatory requirements, implements updates, and responds to health authority questions before, during, and after inspections.

What we are looking for:

• Master or PhD (preferred) in bioconjugation, biotechnology, chemical engineering, organic chemistry or in a life science discipline;
• Preferred industrial experience in GMP environment (>3 years) in bioconjugation, biopharma manufacturing, ideally in the area of BioConjugates or DSP (Mammalian or Microbial);
• Experience in cleaning validation and with regulatory agencies (Swissmedic, FDA, etc.) would be an advantage;
• Excellent communication skills for interaction within the organization and with customers;
• Proficiency in English;  knowledge of German is of advantage;
• Motivated, creative, agile and open-minded;
• Strong team orientation and solution- oriented way of working;
• Eager to foster teamwork and inclusion.