Lonza AG

Senior QA Specialist, Cleaning Validation

📍 CH - Visp

Role and responsibilities

Support the validation specialists during the whole lifetime of the cleaning validation to ensure compliance with Lonza procedures and regulatory guidance QA Review and approval of validation documents (Soil characterization studies, risk assessments/ validation protocols and reports). Support Cleaning Development teams during the development phase. Review and approve Cleaning strategy paper, Swab position assessments etc QA Review and approval of Annual cleaning review reports Ensure the validation procedures are consistently implemented and further developed at Lonza Visp Participation in audits and inspections

Team / description

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.

Qualifications and Skills

  • Academic degree in Chemistry/ Biotechnology or any related field

  • Significant experience in the area of biopharmaceutical 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 required, good German language skills would be an advantage