Senior QA Specialist, Process Validation

Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to Lonza procedures, and in compliance with regulatory guidance Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation Leading the process validation teams including communication with customers Preparation of the validation protocols and reports for the studies performed at manufacturing scale Assessment of changes and deviations during manufacturing for their impact on validation Preparation and maintenance of a documented continued process verification plan

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Academic degree in Chemistry or any related field

• Significant experience in the area of small molecules manufacturing, preferably in a validation function as well as strong background in cGMP

• Broad knowledge of manufacturing processes in GMP environment

• Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)

• Fluency in English language is required; good German language skills are preferred

• Managing internal and external customer relations professionally and effectively