Process Validation Specialist - MSAT Microbial

Process Validation Specialist - MSAT Microbial

Lonza

Visp, Switzerland

We're searching for a Process Validation Specialist - MSAT Microbial to join our team at in Visp, Switzerland. In this role, you'll be instrumental in designing and implementing process validation strategies, preparing essential documentation, and ensuring strict compliance with Lonza's procedures and regulatory guidelines. You'll also play a key part in supporting R&D teams, coordinating validation assessments, and maintaining our continued process verification plan.

Key responsibilities

• Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with Lonza procedures and regulatory guidelines.
• Provide support to R&D teams during the process characterization phase, ensuring the perfect execution of validation activities.
• Review and approve process characterization documents to ensure their alignment with regulatory standards.
• Coordinate validation assessments on changes and deviations, including the approval of deviation and change documents.
• Develop and maintain a detailed continued process verification plan to efficiently implement ongoing process oversight.
• Assess and approve Product Quality Reviews, rigorously ensuring their adherence to quality standards.
• Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities.
• Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
• Process validation specialist in Customer Audits and HA Inspections.

Key requirements:

• Master’s degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent experience.
• Prior experience in GMP-regulated environment.
• Proven experience in project management within Operations, MSAT, Quality, and Compliance.
• Demonstrated ability to interact effectively with various collaborators within the organization and with regulatory agencies (e.g., Swissmedic, FDA).
• Previous experience in microbial cell culture processes and process validation is an advantage.
• Outstanding ability to lead multiple tasks simultaneously and meet tight deadlines.
• Proficient interpersonal skills in English (written and spoken); proficiency in German is appreciated.

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