IS Applications Analyst for Manufacturing Systems
Core
Manage and support Manufacturing Systems including Rockwell PharmSuite eBR and Antares Serialization to ensure regulatory compliance and optimize batch manufacturing processes.
Role type
IS Applications Analyst for Manufacturing Systems
Builds
Electronic Batch Records (eBR) and serialization systems for biopharmaceutical production
Domain
Biopharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
MES eBR software platforms, Rockwell Automation PharmaSuite, validation testing (IQ/OQ/PQ), data integrity principles, FDA 21 CFR Part 11 regulations, GMP/GDP compliance, project management, system configuration, UAT execution, ERP master data coordination, QMS record authoring
Preferred skills
Certificate/ASC/BS in science-related discipline, AI tools for process enhancement
Technologies
Rockwell PharmaSuite, Antares Serialization, ERP systems, ThinManager, VDI, Microsoft Office Suite
Responsibilities
Provide technical and functional support for Manufacturing applications; Design and configure MES eBR systems based on business requirements; Create, manage, and maintain electronic batch records; Oversee User Acceptance Testing of MES recipes; Plan and execute validation tests; Provide training to personnel on eBR and Antares Serialization systems; Analyze batch data and historical records to identify trends and process improvements; Coordinate changes to ERP system master data; Maintain comprehensive documentation of system configurations and validation records; Author QMS records including deviations, CAPAs, and change controls; Collaborate with cross-functional teams to resolve discrepancies; Maintain ThinManager or VDI for software deployment.
Seniority
Mid-level, hands-on IC
