MSAT Process Validation Specialist

MSAT Process Validation Specialist

Lonza

Visp, Switzerland

In this role, you will support process validation for a vaccine manufacturing process and help ensure the highest standards of quality and compliance.

What you will do:

• Define validation strategies for assigned projects in line with Lonza GMP guidelines;
• Prepare process validation protocols and reports, including supporting studies (e.g., hold time, resin lifetime, leachable/extractable studies);
• Assess validation data against acceptance criteria and support investigations of deviations;
• Act as Subject Matter Expert for Non-Conformity Records and Change Requests;
• Assist in developing programs and SOPs to meet industry standards and regulatory requirements;
• Participate in regulatory inspections and customer audits;
• Review and approve Product Quality Reviews.

What we are looking for:

• Master’s degree in Chemistry, Biotechnology, Life Sciences, or related field;
• Experience in project management, preferably in MSAT, Quality, or Compliance;
• Strong stakeholder management skills and ability to interact with regulatory agencies (Swissmedic, FDA, etc.);
• Fluent English communication (written and spoken); German is an advantage;
• Ability to manage multiple tasks and meet deadlines effectively.