Manager, IT Manufacturing Systems

Essential Functions and Responsibilities

• Lead selection, deployment, validation, and operation of computer-based systems for 24x7 manufacturing, laboratory and quality management applications, with a primary focus on leveraging IT solutions for compliant and efficient manufacturing operations.
• Design, management, and documentation of application and data architectures for manufacturing systems.
• Perform role of system owner and subject matter expert for our Emerson Syncade Manufacturing Execution System (MES), leading support, enhancements, and projects to leverage the platform including a major initiative to migrate master batch records to electronic processing.
• Operational activities (e.g., end-user support, break-fix, sustaining compliance) of critical systems including MES, Laboratory Information Management System (LIMS) and Building Management Systems. This includes monitoring, application patch/release management, system backup/recovery, system administration, troubleshooting, change control, deviation and CAPA management, and issue resolution.
• Partner with business teams to map business processes, drive continuous improvement, and implement system enhancements that provide operational efficiencies and cost reductions.

Preferred Education, Skills, and Knowledge

• At least 10 years of hands-on experience working in the biotech/pharma industry implementing and supporting operations of information technology systems; experience with cell and gene therapy manufacturing is preferred.
• Extensive experience implementing and administering manufacturing executions systems (MES), specifically Emerson Syncade Order and Inventory Management, Equipment Tracking, Workflow and Electronic Batch Records.
• Strong working knowledge of the systems development life cycle and its integration with GMP computer system validation (CSV) with the ability to author CSV documents and manage quality deviations, CAPAs and change controls.
• Knowledge, skills and experience as a project manager or a lead project role managing activities, timelines, and resources (both internal and external) to meet targets.
• Experience with other manufacturing systems including Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain) is a plus.