Process Validation Expert MSAT

Switzerland, Visp

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

As a member of the MSAT (Manufacturing Science & Technology) organization in Visp, you are responsible for the successful process validation activities of mammalian manufacturing processes. In this role, you will be responsible for manufacturing process validation in our biopharmaceutical plant, including assessment of process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

Key Responsibilities

• Responsible for the Process Performance Qualification and Continued Process Verification activities.
• Responsible for planning, execution, and documentation of validation protocols and reports in alignment with regulatory expectations (FDA, EMA, ICH) as well as of studies intended to demonstrate the suitability and robustness of manufacturing processes.
• Responsible for the management of technical risks associated with process validation, and project completion aligned with project management goals.
• Works closely with MSAT process experts as well as cross functionally with QA, QC, Manufacturing and Regulatory Affairs to ensure communication of critical process and of technical information to meet the required deadlines.
• Represents Lonza in customer-facing meetings, audits and inspections, providing technical expertise.
• Ensures timely compilation of assessments of change requests and process validation related deviations.
• Responsible to review CMC sections in filing documents and technical content of validation reports. Participates in continuous improvement initiatives and in the development of validation lifecycle strategies.
• Participates in the development and implementation of standardized procedures and processes to drive harmonization and ensure compliance across the Mammalian network.
• Generously shares information and knowledge with other across teams and functions. Demonstrates high integrity.

Key Requirements

• Bachelor's, Master's or PhD degree in biotechnology, chemical engineering or related disciplines.
• Proven experience in managing complex projects.
• Minimum 1 years 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 preferable in Mammalian Manufacturing with 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. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R71895

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