The Automation Engineer-Downstream-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. This role focuses on leading the full Automation scope for delivery of DeltaV logic for Downstream process areas including Buffer Preparation/Hold, Purification - Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing.
The Automation Engineer-Upstream 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. This role focuses on leading the full Automation scope for delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.
What You'll Do
Spearheads the Automation team through activities, such as code configuration within several process areas
Leads the development for various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
Leads the development for various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
Plans and implements the technical direction for small area of responsibility
Leads small teams through Automation changes and Tech Transfers
Makes complex decisions across single Automation systems
Contributes to Automation system hardware and software designs
Serves as on-call support for Automation inquiries and troubleshooting
Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
Conducts training and presents information to team or other stakeholders
Other duties, as assigned
Knowledge and Skills
Personal ownership and proactive collaboration with external business partners and internal stakeholders
Effective communication, both written and oral
Advanced problem-solving skills
Ability to effectively present complex information to others
Ability to provide feedback to others, including leaders
Ability to remain up to date on regulatory and quality requirements for manufacturing