Senior Engineer II, Automation, INT
Core
Lead the design, implementation, and lifecycle management of advanced manufacturing systems for Individualized Neoantigen Therapies (INT) at the intersection of process automation and next-generation therapeutics.
Role type
Senior IC Process Automation Engineer (Pharma/Biotech)
Builds
Scalable, modular automation platforms for lights-out manufacturing of personalized medicine
Domain
Pharmaceutical manufacturing / Biotechnology / Smart Manufacturing
Deliverable
production ML models | product features | infrastructure
Required skills
ISA-95 & ISA-88 standards, DeltaV Control System, S88 batch recipe creation, industrial protocols (HART, Ethernet I/P, OPC, IO), middleware tools (Kepware, OPC servers), in-line PAT integration, RESTful APIs, CSV (IQ/OQ/PQ), 21 CFR Part 11 compliance, robotics/PLC/SCADA familiarity
Preferred skills
Advanced data analytics (SIMCA), tech transfer processes, robotics and fleet management systems, change control processes
Technologies
DeltaV, PLCs, SCADA, AVEVA PI, SIMCA, Kepware, OPC, RESTful APIs
Responsibilities
Define and implement automation architectures aligned with ISA-95/ISA-88; Lead CAPEX projects from concept through commissioning; Partner with cross-functional teams (MSAT, Manufacturing, Quality, IT); Oversee deployment of DeltaV, PLCs, SCADA, and robotics; Develop APIs and integrations across data lakes, WMS, and ERP; Ensure adherence to 21 CFR Part 11 and Annex 11; Identify and implement process improvements for reliability and scalability; Provide technical leadership and mentorship to cross-functional teams.
Seniority
Senior, hands-on IC with strategic oversight