Manufacturing Systems Engineer: Automation
Core
Design, build, and maintain process automation systems and control strategies for GMP drug substance manufacturing operations.
Role type
Manufacturing Systems Engineer (Automation)
Builds
Robust process automation systems for new plant operations
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, process control engineering, GxP compliance, computerized systems validation, data integrity assessments, change control management, root cause analysis, functional safety, vendor FAT support, commissioning and qualification, continuous improvement, technical writing
Preferred skills
Electrical/Computer/Chemical Engineering degree, biopharmaceutical production facility automation experience, programming of automation and field instrumentation, OPC/Foundation Fieldbus/Profibus integration, GAMPs and 21 CFR Part 11 knowledge
Technologies
Emerson DeltaV, OPC, Foundation Fieldbus, Profibus, GAMPs, 21 CFR Part 11
Responsibilities
Develop and maintain process control systems; collaborate with stakeholders to synthesize process requirements; provide documentation for delivered solutions; support QA in computerized systems validation; perform Data Integrity Assessments; support vendor FAT; drive change controls and CAPAs; support technical root cause analysis; prepare/review SOPs and cGMP documents
Seniority
Mid-Senior, hands-on IC