IT OT Manufacturing Systems Application Engineer
Core
System Owner and Local Product Owner for Manufacturing IT/OT Applications in a 24x7 Good Manufacturing Practice (GMP) environment, ensuring support for Product Transfers and Make/Assess/Release.
Role type
Senior IC Manufacturing IT/OT Application Engineer
Builds
SCADA systems, PLCs, HMIs, and associated manufacturing infrastructure for biopharmaceutical production.
Domain
Biopharmaceutical manufacturing, Industrial OT, GMP compliance
Deliverable
production ML models | product features | infrastructure
Required skills
SCADA system implementation and management, PLC/HMI configuration and support, Rockwell FactoryTalk administration, GAMP5 and cGMP regulatory compliance, industrial communication protocols (OPC UA/DA, EtherNet/IP), validation planning and execution, disaster recovery planning
Preferred skills
Manufacturing Execution Systems (MES) experience, Distributed Control Systems (DeltaV) knowledge, LIMS/ERP integration, Industrial IoT trends, vendor negotiation
Technologies
Rockwell FactoryTalk, Studio 5000, RSLogix, ThinManager, SAP, LIMS, DeltaV, OSI PI Data Historian, Veeva, Condor, eVal Roche
Responsibilities
Procurement, development, integration, modification, operation, maintenance, validation, and retirement of SCADA systems; Daily maintenance including incident response, troubleshooting, and system health monitoring; Execution of validation activities including protocol authoring and test execution; Coordination with global IT and local stakeholders for compliance and system upgrades; Development and maintenance of training and system lifecycle documentation; Lead or coordinate technical discussions and vendor negotiations; Perform user account auditing and provisioning; Develop and practice Disaster Recovery and backup/restore procedures.
Seniority
Senior, hands-on IC
