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 productsDefine, track and maintain timelines, milestones and deliverablesCoordinate inputs from multiple stakeholders (MSAT, QA, QC, Production, Engineering) during document preparation and reviewSupport the drafting, review and finalization of CPV and PQR reports, ensuring:completeness and data consistencycompliance with internal SOPs, GMP requirements and regulatory expectationsMonitor progress of activities and identify potential delays or roadblocksEscalate issues and risks in a timely manner to the responsible Process Validation/MSAT leadSupport data review, trending and analysis activities related to CPVSupport 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 goalsSupport the resolution of process issues that may arise during manufacturing, considering all regulatory requirementsSupport the execution of GMP risk analysis for the manufacturing processesGet 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 reportsSupport continuous improvement of process performanceWhat we are looking for:Bachelor’s or Master’s degree in Biotechnology,Chemistry, Chemical, Biochemical Engineering, Pharmacy or a related scientific or technical disciplineStrong interest in microbial manufacturing processes and process lifecycle managementBasic understanding of bioprocess fundamentals, such as: microbial upstream and/or downstream processesprocess parameters and their impact on product qualityKnowledge of process validation principles, including: validation lifecycle conceptsContinued Process Verification (CPV)Product Quality Review (PQR) activitiesBasic knowledge of statistics, including: data trending and variabilityability to interpret process and quality data at a fundamental levelAbility to support process monitoring and data review activities under guidanceFamiliarity with or strong interest in GMP environments and regulated manufacturingGood organizational and planning skills, with the ability to manage multiple tasks and timelinesAbility to work effectively in cross-functional teams, interacting with Manufacturing, Quality and Quality ControlStructured, analytical mindset with problem-solving orientationHigh attention to detail and interest in technical documentation and data integrityGood knowledge of English, both written and spokenEvery 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. Reference: R73248