MSAT Deviation Manager

MSAT Deviation Manager

Lonza

Visp, Switzerland

The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for a MSAT Bioconjugates Process Expert (m/f/d) to support our growth project Vibe-X, a customer-dedicated plant for a conjugated vaccine. In this role, you will be responsible for the successful commissioning of the facility and later realization of the PPQ and further production campaigns. You will play a crucial role in the network between the different departments as manufacturing, development, quality assurance and control. Become part of this exciting opportunity and apply now!

What you’ll do:

• Initiate and manage deviation records within the Lonza QMS System (TrackWise) to ensure timely and effective resolution.
• Plan, complete, and lead Root Cause Analysis (RCA) events, engaging relevant departments and internal and External collaborators.
• Interpret and apply cGMP principles while reviewing GMP documentation such as SOPs, logs, and batch records.
• Facilitate and participate in meetings to align collaborators on investigation strategy and outcomes.
• Collaborate with Cross functional teams to identify and implement corrective and preventive actions (CAPAs) to facilitate deviation closure.
• Ensure deviations and investigations are completed and closed in alignment with batch release timelines.
• Work closely with the, Operations, MSAT and Quality Assurance (QA) teams to support deviation closure and address customer-related queries with a high standard of accuracy.
• Engage in process improvement projects that improve our operational efficiency and product quality.

What we’re looking for:

• Master or PhD or equivalent experience in Biotechnology, Chemical Engineering or related fields.
• Familiarity with cGMP regulations and quality systems.
• Good understanding of Lean Six Sigma.
• Proficient in using Track Wise or similar Quality Management Systems.
• Proven experience in performing Root Cause Analysis using effective tools and methodologies.
• Strong technical writing and communication skills, with the ability to articulate complex scientific topics and recommendations clearly.
• Outstanding organisational skills to manage multiple tasks and meet deadlines.
• Fluency in English required, German would be an advantage.

Apply Now