Manufacturing Systems Engineer: Automation - Delta V
Core
Develop, maintain, and troubleshoot process control systems and automation platforms for GMP drug substance manufacturing operations.
Role type
Manufacturing Systems Engineer (Automation)
Builds
Robust process automation systems for a new biopharmaceutical plant
Domain
Biopharmaceutical manufacturing / Industrial Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Emerson DeltaV DCS programming and maintenance, GxP compliance, Data Integrity Assessments, Change Control management, root cause analysis, functional safety, vendor FAT support, commissioning and qualification (IV/ACO), SOP development, cross-functional collaboration
Preferred skills
Electrical/Computer/Chemical/Biotech Engineering degree, process control engineering design, lifecycle management of field instrumentation, OPC/Foundation Fieldbus/Profibus integration, GAMPs and 21 CFR Part 11 application, advanced troubleshooting of bioreactors and chromatography systems
Technologies
Emerson DeltaV, OPC, Foundation Fieldbus, Profibus, GAMPs, 21 CFR Part 11
Responsibilities
Develop and maintain process control systems on Emerson DeltaV DCS; Collaborate with stakeholders to synthesize process requirements and develop automation solutions; Provide clear documentation for delivered solutions; Support QA partners in computerized systems validation; Perform Data Integrity Assessments; Support vendor FAT to ensure control strategy and software code meet requirements; Drive completion of Change Controls, CAPAs, and Deviations; Support technical root cause analysis and incident investigations; Support commissioning and qualification efforts including IV/ACO; Prepare and review Standard Operating Procedures (SOP) and cGMP documents; Drive continuous improvement for process automation systems; Support day-to-day operations including rotational on-call support
Seniority
Mid-Senior level, hands-on IC
