Process Development Engineer 3, MSAT
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.
As a Process Development Engineer, you will be part of a team that leads the technology transfer of new processes into Lonza Singapore production facility, providing process support & monitoring and performing process investigations to ensure process robustness.
- Support the timely and successful transfer of the customer's manufacturing process into the Lonza Singapore production facility. Work with other team members to support technology transfer
- Perform/support experiments in the MSAT scale-down process lab to support process technology transfer. Follow all applicable lab safety policies.
- Provide floor and on-call support for projects being transferred
- Work closely with customers to identify and resolve tech transfer gaps and process issues
- Write master batch records and develop operator training packages
- Deliver pre-campaign training and perform post-campaign reviews of assigned processes.
- Support investigations into process issues or deviations, write minor/major deviations are assigned.
- Support/lead pre-campaign preparation activities (BR review, training, change requests) for assigned projects per pre-defined schedule
- Provide floor and on-call support during production. Escalate issues to management appropriately and interface with customer on issue resolution
- Compile and disseminated daily process updates
- Ensure presence on the floor to support production and MSAT review of operations
- Support investigations into process issues or deviations, write minor/major deviations
- Support/lead the investigation into process trends to support process monitoring requirements, support preparation of APR and CPV reports, perform work-stages to support customer BLA filing
- Keep current appropriate databases with MFG process data and analyze to monitor run to run consistency for manufacturing operations and identify opportunities for improvement.
- Support inspections and audits by customer and regulatory authorities as required
- Any other duties as assigned by your Supervisor/Manager.
- Degree in Chemical Engineering, Biochemical Engineering, Biochemistry/ Chemistry/ Microbiology or related discipline.
- Exposure in Biotechnology process development, process support, research or a related manufacturing environment is desirable.
- Prior hands-on technical experience (in a laboratory or manufacturing environment) is desirable.
- Knowledge of Excel as well as Statistical Data Analysis tools.
- Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.
- Excellent technical writing skills, ability to provide attention to detail is essential.
- Demonstrated track record in completing projects under tight timelines.
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 achieve 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.