About the role
The Process Engineer II (Upstream) supports and leads troubleshooting of upstream manufacturing operations, conducts root cause analyses, drives process improvements, manages technology transfers, and contributes to global manufacturing science initiatives within a biopharmaceutical environment.
BiopharmaOnsiteManufacturing Sciences
Key Responsibilities
- Support site manufacturing upstream activities through planning and executing process investigations, impact assessments, and root cause analysis; collaborate with cross‑functional teams and analyze process trends as part of the CPV program
- Escalate and investigate out‑of‑trend issues and lead process investigations to implement
Requirements
- Support site manufacturing upstream activities through Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis.
- Proactively investigate where required to ensure process robustness.
- Performing risk assessment, drafting required technical transfer and process control strategy documents and updating lifecycle documents.
- Education and Experience Requirements
- Bachelor's Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 3 - 4 years of relevant experience or Master's Degree with 2 years of relevant work experience or a fresh PhD in the relevant technical area.
- Hands-on experience with cell culture/ upstream processes and/or downstream processes in a manufacturing or development environment.