MSAT Process Validation Specialist

MSAT Process Validation Specialist (m/f/d)

Lonza

Switzerland, Visp

Today, Lonza is a global leader in life sciences operating across three continents. We value talented people working together to devise ideas that help businesses and ultimately improve the world. This role is part of our MSAT (Manufacturing Science & Technology) organization in Visp and focuses on successful process validation activities of mammalian manufacturing processes.

• Responsible for Process Performance Qualification and Continued Process Verification activities.
• Plan, execute, and document validation protocols and reports in alignment with regulatory expectations (FDA, EMA, ICH) and studies that demonstrate the suitability and robustness of manufacturing processes.
• Manage technical risks associated with process validation and complete projects aligned with project management goals.
• Work closely with MSAT process experts and cross‑functionally with QA, QC, Manufacturing and Regulatory Affairs to ensure communication of critical information and meet required deadlines.
• Represent Lonza in customer‑facing meetings, audits and inspections, providing technical expertise.
• Ensure timely compilation of assessments of change requests and process‑validation related deviations.
• Review CMC sections in filing documents and technical content of validation reports; participate in continuous improvement initiatives and validation lifecycle strategies.
• Develop and implement standardized procedures and processes to drive harmonization and ensure compliance across the Mammalian network.
• Generously share information and knowledge with other teams and functions, demonstrating high integrity.

• Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines.
• Proven experience in managing complex projects.
• Minimum 1 year of experience in process validation within a cGMP‑regulated biopharmaceutical environment. Experience in process development, process scale‑up and/or manufacturing is a plus.
• Working experience in biopharma manufacturing and/or process development, preferably in mammalian manufacturing with a strong understanding of upstream and downstream processes in mammalian cell culture.
• Good understanding of GMP.
• Excellent communication, technical writing and stakeholder management skills.
• Fluency in English.

Every day, Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and the environment, and we act with the utmost integrity.

Reference: R72038

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