MSAT Validation Expert (7035)

CTC Resourcing Solutions AG seeks a Senior MSAT Validation Expert in Visp to lead process and cleaning validation activities within a large-scale mammalian facility, ensuring strict cGMP compliance.

This position serves as a key member of the MSAT Validation team at a major biopharmaceutical production site in Visp. The primary objective is to oversee and execute validation strategies for process and cleaning activities, thereby guaranteeing that all manufacturing operations meet rigorous quality standards and regulatory requirements.

Responsibilities

• Develop validation strategies for assigned process or cleaning projects.
• Draft, author, and review validation protocols and final reports to ensure alignment with regulatory norms.
• Approve documentation related to process and cleaning validation.
• Collaborate with internal stakeholders during the execution of validation activities.
• Evaluate validation data against predefined acceptance criteria and assist in investigating any deviations.
• Serve as the Subject Matter Expert for non-conformity records and change control requests.
• Support Performance Qualification (PQ) studies by authoring relevant protocols and reports.
• Represent the organization in meetings with external customers.
• Contribute to the creation and maintenance of Standard Operative Procedures (SOPs) to adhere to industry standards.
• Act as the primary validation expert during inspections by healthcare authorities and customer audits.

Requirements

• Hold a valid working/residency permit or possess Swiss or EU citizenship.
• Possess a Master’s degree or PhD in biotechnology, life sciences, or a closely related field.
• Demonstrate practical experience in process validation within a cGMP-regulated biopharmaceutical setting.
• Show a track record of managing complex projects, preferably within MSAT or Quality functions.
• Be fully fluent in English, both written and spoken.

Nice to have

• Prior experience in cleaning validation.
• Knowledge of upstream and downstream processes, particularly in mammalian manufacturing.
• Background in process development, scale-up, or manufacturing, with a focus on mammalian cell culture.
• Experience interacting with regulatory bodies such as Swissmedic or the FDA.
• Proficiency in German is considered an asset.

About the company

The client is recognized as a global market leader in the production and process support of active pharmaceutical ingredients across chemical and biotechnology sectors.

• Operates as a global leader in pharmaceutical ingredient production and process support.