Senior Process Validation Expert

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

Key responsibilities:

• Develop and define the process validation strategies for the assigned projects in the Mammalian Large Scale facility of Lonza Visp.
• Prepare/Author process validation protocols and reports, including supporting studies (e.g., hold time, resin lifetime, leachable/extractable studies) according to Lonza procedure and in compliance with regulatory.
• Support Process Development (PD) teams during the process characterization phase.
• Preparation and maintenance of a detailed continued process verification plan.
• Assess, review and approve Product Quality Reviews (PQR).
• Reviewing and approving of process related documents.
• Assess process validation data against acceptance criteria and support investigations of deviations (and approve DR).
• Act as a Subject Matter Expert (SME) for non-conformity records and change requests (responsible for the process validation assessment and approval).
• Represents Lonza in customer-facing meetings.
• Assist in developing programs and Standard Operative Procedures (SOP) to meet industry standards and regulatory requirements.
• Act as process validation SME during inspections by healthcare authorities and customer audits.

Key requirements:

• Master’s or PhD degree in biotechnology, life sciences, or related disciplines. 
• Working experience in process validation within a cGMP-regulated biopharmaceutical environment.
• Proven experience in managing complex projects, ideally in MSAT or Quality.
• Ability to manage multiple tasks and meet deadlines effectively.
• Strong understanding of upstream and downstream processes (preferably in mammalian manufacturing).
• Exposure to process development, scale-up, and/or manufacturing (preferably mammalian cell culture).
• Experience engaging with regulatory agencies (Swissmedic, FDA, etc.).
• 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.