Senior Process Expert (m/f/d) MES – Drug Product
Today, Lonza is a global leader in life sciences operating across three 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.
In order to support our continued growth, we are looking for experienced Senior Process Expert MES with a relevant background in MES (Emerson Syncade) and Drug Product / sterile manufacturing to join our talent community in Visp, Switzerland. Become part of this exciting opportunity and join our team by applying for this position! The role will be responsible for designing / authoring recipes / MBRs in MES (Emerson Syncade) and providing overall MES support.
Authors and adapts MES/PCS recipes based on the Drug Product processes
Coordinates multiple stakeholders to collect recipe inputs
Defines the overall concept for MES recipes used in Drug Product Operations to enable an easy and fast creation as well as adaption to new customer products
Creates and maintains relevant GMP documents (Installation Qualification, Operational Qualification, Performance Qualification, SOP’s, etc.)
Plans, prepares and executes qualification and validation activities
Provides front line MES support, working with the manufacturing teams (operators), plant engineers and QA operations
Leads MES related changes, CAPAs, and CAPA effectiveness checks within required timelines and through GMP systems (e.g. Trackwise)
Provides MES training for all end users
Plans, prepares and executes MES related improvement and innovation projects
Acts as MES Subject Matter Expert during customer audits and visits, maintain MES at inspection readiness level and provide the necessary support
Contributes to future projects (e.g. additional filling lines) as MES Subject Matter Expert
Experience in MES recipe authoring, preferably in Emerson Syncade
Knowledge of PCS is preferable, ideally in Emerson DeltaV
Process knowledge in the area of sterile drug product is preferable
Familiar with working in regulated environment, knowledge of cGMP, 21CRF part 11 and validation requirements
High proactivity/ initiative and independence to lead assigned tasks from start to finish
Very good organizational skills, self-management and ability to work in self-organizing teams
Very good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor
Ability to handle multiple complex tasks at the same time and under time pressure
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.