About the role
AI summarisedAs a Process Engineer, you will serve as the system owner for biotechnology manufacturing facilities in ASM, providing critical operation and New Product Introduction (NPI) support for multiple biologics products. This role ensures uninterrupted plant operations by managing process equipment, driving investigations, and maintaining a validated state for all manufacturing processes.
BiotechOnsiteEngineering
Key Responsibilities
- Serve as the system owner for biotechnology manufacturing facility equipment within the Process Engineering team.
- Provide operation and New Product Introduction (NPI) support for multiple biologics products and process equipment.
- Ensure appropriate and timely completion of cGMP maintenance activities with minimal disruption to manufacturing.
- Act as Subject Matter Expert (SME) for process equipment, ensuring it operates and performs as intended in a validated state.
- Manage, plan, and implement changes to processes and equipment.
- Drive deviation investigations related to process interruptions and equipment performance.
- Develop and maintain equipment maintenance programs.
- Serve as a liaison between corporate engineering and site operations regarding new equipment design or modifications.
Requirements
- Ability to collaborate closely with team members and SMEs to sustain daily operations.
- Proven ability to resolve operational challenges while maintaining safety and compliance.
- Experience or knowledge of GMP manufacturing processes is essential.
- Willingness to gain broad exposure to all key aspects of GMP manufacturing.
- Ability to interact cross-functionally with various site functions for production success.