Trainee MSAT Validation

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

MSAT Microbial provides end-to-end technical expertise across the microbial manufacturing lifecycle, acting as the key link between process knowledge, manufacturing execution and product quality.

The team serves as process experts for microbial upstream and downstream processes, supporting process understanding, troubleshooting, and continuous improvement during clinical and commercial manufacturing. In parallel, MSAT Microbial is responsible for process validation activities, including lifecycle management of process validation, Continued Process Verification (CPV) and Product Quality Review (PQR), ensuring sustained process performance and regulatory compliance. Through close collaboration with Manufacturing, Quality, Engineering and other cross-functional partners, MSAT Microbial ensures robust, compliant and scalable processes, supporting safe, reliable and efficient drug substance supply.

As an MSAT Validation / MSAT Process Expert Trainee, you will gain hands-on insights into the core MSAT validation and process-related activities supporting microbial manufacturing operations.

 What you will do:

• Support the planning and coordination of Continous Process Validation (CPV) and annual Product Quality Review (PQR) activities for assigned products

• Define, track and maintain timelines, milestones and deliverables

• Coordinate inputs from multiple stakeholders (MSAT, QA, QC, Production, Engineering) during document preparation and review

• Support the drafting, review and finalization of CPV and PQR reports, ensuring:

  • completeness and data consistency

  • compliance with internal SOPs, GMP requirements and regulatory expectations

• Monitor progress of activities and identify potential delays or roadblocks

• Escalate issues and risks in a timely manner to the responsible Process Validation/MSAT lead

• Support data review, trending and analysis activities related to CPV

• Support MSAT Process Experts core activities in the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals

• Support the resolution of process issues that may arise during manufacturing, considering all regulatory requirements

• Support the execution of GMP risk analysis for the manufacturing processes

• Get trained on directly interaction with customers during campaign preparation, execution and closure including daily reporting of batch status and performance.

• Support timely compilation of process related deviations, change requests and campaign reports

• Support continuous improvement of process performance

• Bachelor's or Master's degree in Biotechnology,Chemistry, Chemical,  Biochemical Engineering, Pharmacy or a related scientific or technical discipline

• Strong interest in microbial manufacturing processes and process lifecycle management

• Basic understanding of bioprocess fundamentals, such as:

  • microbial upstream and/or downstream processes

  • process parameters and their impact on product quality

• Knowledge of process validation principles, including:

  • validation lifecycle concepts

  • Continued Process Verification (CPV)

  • Product Quality Review (PQR) activities

• Basic knowledge of statistics, including:

  • data trending and variability

  • ability to interpret process and quality data at a fundamental level

• Ability to support process monitoring and data review activities under guidance

• Familiarity with or strong interest in GMP environments and regulated manufacturing

• Good organizational and planning skills, with the ability to manage multiple tasks and timelines

• Ability to work effectively in cross-functional teams, interacting with Manufacturing, Quality and Quality Control

• Structured, analytical mindset with problem-solving orientation

• High attention to detail and interest in technical documentation and data integrity

• Good knowledge of English, both written and spoken

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.