Senior Process Validation Expert(m/w/x)

Anforderungen

• 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

Aufgaben

• Develop process validation strategies for assigned projects
• Prepare and author process validation protocols and reports
• Conduct supporting studies, including hold time and resin lifetime assessments
• Support Process Development teams during process characterization
• Maintain a detailed continued process verification plan
• Assess and approve Product Quality Reviews
• Review and approve process-related documents
• Evaluate process validation data against acceptance criteria
• Support investigations of deviations and approve deviation reports
• Act as a Subject Matter Expert for non-conformity records and change requests
• Represent Lonza in customer-facing meetings
• Assist in developing programs and Standard Operating Procedures to meet industry standards
• Act as process validation SME during inspections and audits

Berufserfahrung

Ausbildung

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