Senior Process Engineer MSAT (USP)

Senior Process Engineer MSAT (USP)

Apply locations SG - Tuas, Singapore time type Full time posted on Posted 27 Days Ago job requisition id R61859

Today, Lonza is a global leader in life sciences operating across three continents. 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.

The Senior Process Engineer, Upstream Process, MSAT will be responsible for the transfer of cell culture or purification stages from the customer's manufacturing process(es) to Lonza Singapore. They will manage the preparation, execution, monitoring, and post-campaign activities for these stages. Additionally, they will investigate process trends, issues, or deviations.

Key Responsibilities:

1. Lead investigations into process trends, issues or deviations involving multiple departments and customers.
2. Write change requests and aim to implementation.
3. Review cell culture or purification process manufacturing batch records and provide technical input to MFG technical document writing specialists.
4. Identify training needs and provide training materials for MFG operators on cell culture or purification process batch records. Work with MFG to update process batch records to enable robust manufacturing operations.
5. Assist with plant start-up and pilot/commercial runs, conduct technical investigations, and contribute to technical reports for resolving deviations and troubleshooting process issues in cell culture or purification operations.
6. Design and perform/support small-scale experiments/studies in lab to support technology transfer or investigations. Follow all applicable lab safety policies.
7. Support preparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, perform work-stages to support customer BLA filing.
8. Maintain process databases and monitor batch-to-batch consistency of operations.
9. Support inspections and audits by customers and regulatory authorities.
10. Offer mentorship and exchange process knowledge with MSAT team members and other departments.
11. Any other duties as assigned by your Supervisor/Manager.

Key requirements:

1. Degree/Masters in Biological Sciences, Biochemical/Chemistry/Microbiology or any related subject area.
2. Minimum 5-10 years of experience in Biotech Industry experience in cell culture experimental technique and Purification in biotech industry. Good Manufacturing Practices, US/EU regulations, supervision.
3. Demonstrates critical thinking skills in problem solving and decision making.
4. Attention to detail and high level of accuracy.

Every day, Lonza’s products and services have a positive impact on millions of people. 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.