About the position
The Automation Engineer 2 will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. During the project phase, the main responsibility as a Computer System Validation (CSV) Automation Engineer 2 will be to prepare validation documentation and contribute to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems. This role will partner with other departments locally and other sites to align strategies and procedures. Once operational, this role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement initiatives and supporting regulatory agency and third-party inspections.
Responsibilities
- Performs Automation activities, such as code configuration, document development, and test execution within several process areas
- Delivers accurate and on-time Automation work
- Creates standard code utilizing medium complexity control strategies
- Collaborates with senior Engineers to develop various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
- Collaborates with senior Engineers to develop various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
- Serves as on-call support for Automation inquiries and troubleshooting
- Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
- Other duties, as assigned
Requirements
- Bachelor's degree in Chemical, Electrical, or Mechanical Engineering or other relevant field
- 2 years of Automation, Instrumentation & Controls, or other relevant technical experience
Nice-to-haves
- 3+ years of Automation experience
