Sr. Manager, Automation, Controls and Calibration

Integra LifeSciences • Plainsboro Township, NJ

1d • $125,350 - $172,500

About The Position

The Sr. Manager of Automation, Controls and Calibration reports to the Director of Engineering and is responsible for support of controls, automation, and equipment calibration related to manufacturing in CMC Buildings 105 and 109. The role owns the Building Monitoring System (BMS) in Buildings 105 and 109, the Jace system in B105 CMC, and other control systems supporting Facilities, Manufacturing, and Labs. Systems and equipment include production instrumentation, Rockwell and Modicon PLCs, PanelView, Rockwell FactoryTalk, McQuay control systems, motor control panels, AC/DC variable frequency drives, and system development life cycle activities.

The position leads the site calibration and metrology program, supports automated manufacturing and laboratory systems, and manages automation and calibration staff, vendors, projects, documentation, compliance, and system lifecycle activities. It provides subject-matter expertise for manufacturing processes, facility systems, and project planning, design, and implementation. The role supports cGMP operations and computer system validation, maintains validated software inventories and backups, and coordinates automation and network-related work with system users and GAC/IT.

The position reports directly to the Director of Engineering and has direct reports including the Calibration Manager, Automation and Control Engineers, and Technicians. It may require on-call emergency support, availability during scheduled shutdowns and emergencies, flexible hours, and minimal travel for training. The position involves moving throughout company buildings and locations, occasional lifting of items up to 25 pounds, and domestic and international travel by car, train, or airplane as required.

Requirements

• Bachelor's degree in electronics, electrical engineering, or another related technical field, with 15 or more years of experience.
• 10 or more years of experience managing engineering staff, external vendors, and activities.
• Solid understanding of electricity, electrical circuits, and analog and digital input/output devices.
• Ability to read and understand electrical diagrams and P&IDs.
• Knowledge of Allen-Bradley PLC programming software, including RSLogix, RSLinks, FactoryTalk, and ControlLogix.
• Knowledge of Ethernet and BACnet communication protocols.
• Ability to multitask, prioritize, and work in a fast-paced environment.
• Ability to work with minimal supervision.
• Available to travel minimally for training purposes.
• Familiarity with high-voltage equipment operation, maintenance, and safe test procedures.
• Understanding of cGMP, cGDP, and Computer System Validation (CSV).
• Working knowledge of Lockout/Tagout (LOTO) procedures.
• Working knowledge of Facility Monitoring and Building Management Systems.
• Record of safe operations and working knowledge of safety standards for plant environments.
• Proficiency in Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).
• Strong writing and communication skills.
• Knowledge of personal computers and software such as MS Project, Word, Excel, and PowerPoint.
• Experience with CMMS and CMS software.
• Availability during scheduled shutdowns and emergency situations, and ability to work flexible hours.
• Ability to sit, listen, speak, and move throughout various areas of a building; travel across company locations as needed; periodically lift or move items up to 25 pounds; and travel domestically and internationally by car, train, or airplane as required.

Nice To Haves

• Knowledge of Modicon and Siemens PLC programming software.
• Prior experience implementing and managing similar control/automation systems in a medical device or pharmaceutical environment.

Responsibilities

• Lead the site calibration and metrology program supporting approximately 2,500 assets and more than 3,000 annual calibration events.
• Define preventive maintenance activities for instrumentation and control equipment.
• Serve as a subject-matter expert for automated manufacturing processes and facility systems.
• Assist Operations and Quality with day-to-day operation and troubleshooting of automated manufacturing and laboratory systems.
• Support and mentor Automation and Control Engineers and Maintenance Technicians.
• Serve as a subject-matter expert during project planning, design, and implementation.
• Ensure cGMP automation equipment and systems have minimum documentation in accordance with ISPE GAMP5 guidelines.
• Support computer system validation for cGMP automation equipment, including development of documentation in accordance with ISPE GAMP5 guidelines.
• Manage documentation according to Good Documentation Practices (GDP).
• Complete assigned work in accordance with cGMPs, OSHA, EPA, and other federal and state regulations.
• Support automation team ownership of automation SOPs and system drawings.
• Perform system administrator duties, including managing system users.
• Perform annual reviews of automation systems.
• Provide system support for Non-Conformance and Corrective Action Preventive Action investigations; own or support related documentation as needed.
• Communicate possible non-conformances and other compliance risks to the Director of Facility Engineering.
• Manage automation system changes according to site change-control procedures.
• Assess systems and propose automation projects to improve quality, safety, cost, or production.
• Make small- to medium-scale automation code updates for projects while following Integra change-control procedures.
• Provide on-call emergency support when subject-matter expertise is needed.
• Analyze, troubleshoot, diagnose, and repair equipment promptly to minimize production downtime.
• Manage automation projects and vendors delivering new systems, changes to existing systems, or system retirements in support of business objectives.
• Maintain system inventory information and backups of validated software.
• Support network maintenance and projects owned by GAC/IT; communicate and coordinate network or system interruptions with users.
• Set departmental objectives and goals in alignment with plant priorities.
• Contribute to development of plant objectives, goals, and strategies.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• Savings plan (401(k))
• Employees may be eligible for bonus, commission, equity, or other variable compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior