MSAT Associate Process Engineer
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.
This position is responsible for being the primary technical support person for manufacturing processes. This person has experience with one manufacturing process. The supervisor provides detailed instructions on new projects and assignments, as this level of Process Associate is expected to perform routine work within established policies and procedures for the role. The individual is not expected to be a subject matter expert for any aspect of the role and it is expected that questions on tasks or issues will be raised by this individual when clarification or greater technical expertise is required.
- 50% - Process Transfer and Process Support: Performs most of the functions associated with process support, e.g. develop process understanding, modify / review Process Descriptions and Batch Records, author / review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess minor deviations and process changes).
- 15% - Deviations / Problem Solving / Data Analysis: Assesses minor deviations and assesses non-product quality impacting deviations with assistance. Performs intermediate level data analysis such as non-standard calculations, means comparison, control charting.
- 15% - Documentation and Change assessments: Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently. Assesses change controls for impact of any change to the process, equipment or procedures with assistance.
- 10% - Represent MSAT: Represents MSAT on project teams and interfaces with customer technical and quality representatives. Represents MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings). Participates in Customer Audits.
- 10% - Training: Follows all training and policy guidelines established for the facility as well as all cGMP requirements. Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. ComplianceWire, SAP Learning Portal) and completing all training in a timely fashion.
- Bachelor of Science degree in Biotechnology area, Biological Sciences, or Chemical Engineering.
- Working experience in biotech industry, specifically in tech transfer, as well as in process development, process scale up, or manufacturing.
- Working experience with large scale (2 kL + experience a plus) manufacturing support (mammalian preferred), cGMP and US / EU regulations.
- Knowledge of cell biology, protein structure, scale up, chromatography, Ultrafiltration/Diafiltration, virus filtration and basic knowledge of statistical data analysis.
- Strong communication skills. Able to clearly express ideas and point of view both verbally and in writing. Has good inter-personal skills. Shows commitment and dedication and strives to be ahead of schedule.
- Ability to share 24/7 on-call support while process is being manufactured.
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.