Sr. Manager, Automation, Controls and Calibration

Changing lives. Building Careers.   Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Sr. Manager of Automation, Controls and Calibration will report to the Director of Engineering and is directly Responsible for overall support of all controls/automation and calibration of equipment in CMC Buildings 105 and 109 related to manufacturing, ownership of the Building Monitoring System (BMS) in Buildings 105 and 109, the Jace system in B105 CMC, and all other control systems related to Facilities, Manufacturing and Labs. Such equipment includes but is not limited to: Production Instrumentation • Rockwell PLCs • Panel View System • Rockwell Factory Talk • Modicon PLCs • McQuay Control systems • Motor Control Panels • AC/DC Variable Frequency Drives • System Development Life Cycle REPORTING & MANAGEMENT SCOPE SUPERVISION RECEIVED Under direct supervision of the Director of Engineering   SUPERVISION EXERCISED Direct Reports:  • Calibration Manager • Automation and Control Engineers and Technicians   KEY RESPONSIBILITIES Lead the site calibration and metrology program supporting approximately 2,500 assets and over 3,000 annual calibration events. Define preventive maintenance activities for instrumentation and control equipment. Serve as a subject matter expert (SME) for automated manufacturing processes and facility systems. Assist Operations and Quality in day-to-day running and troubleshooting of automated manufacturing systems and laboratory systems. Provide support and mentoring to Automation and Control Engineers and Maintenance Technicians. Serve as a subject matter expert (SME) during project planning, design and implementation. Ensure that all cGMP automation equipment and systems have the minimum documentation as per the ISPE GAMP5 guidelines. Support the computer system validation activities for all cGMP automation equipment, including development of documentation as per the ISPE GAMP5 guidelines. Manage all documentation following Good Documentation Practices (GDP). Complete all assigned tasks following cGMPs, OSHA, EPA and other Federal and State regulations. Support automation team ownership of all automation Standard Operating Procedures (SOP)s and system drawings. Perform system administrator role, including managing system users. Perform annual system review for all automation systems. Provide system support during Non-Conformance (NC's) and Corrective Action Preventive Actions (CAPA) investigations. Own or support NC/CAPA documentation as needed. Communicate possible NCs or other compliance risks to the Director of Facility Engineering. Manage automation system changes in accordance with site change control procedures. Perform system assessments and propose automation projects geared to increase quality, safety, cut cost or increase production. Perform small to medium automation code updates associated with small to medium projects (while following the Integra Change Control procedures) Provide on-call emergency support as required (in the event SME assistance is needed). Support analysis, troubleshooting, diagnostics and repair of equipment in a prompt manner that will minimize production downtime. Manage automation projects and automation vendors to deliver new systems, change existing systems, or retire existing systems to support business objectives. Maintain system inventory information and backups of all validated software. Support network maintenance and projects owned by GAC/IT. Communicate and coordinate all network or system interruptions with system users. Set departmental objectives and goals in accordance with the plant priorities. Contribute to the development of plant objectives,