Trainee MSAT Validation​/MSAT Process Expert

Trainee MSAT Validation / MSAT Process Expert

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…