Director, Engineering (Reliability)

Description:

The Director, Engineering (Reliability) is responsible for providing tactical leadership and technical oversight for all site facilities maintenance aspects, utilities, automation systems, and equipment reliability across multiple pharmaceutical manufacturing site(s) in New Jersey Region. This role ensures robust, compliant, and efficient operation of facilities and automated systems that support production, packaging, laboratories, and site infrastructure within a 24/7 operation. The Director will lead multidisciplinary Maintenance Teams for facility systems, Process Equipment systems, Controls Systems, Utilities Systems, and Sanitization Systems while ensuring adherence to cGMP, FDA, OSHA, and environmental regulatory requirements. The ideal candidate brings extensive experience with deep knowledge of complex automated machinery, reliability engineering, Predictive Maintenance, Root Cause Analysis, FMEA, Asset Life Cycle Management, Spare Parts Optimization, Maintenance Excellence and operation Reliability. The candidate must have exposure to FDA regulated environment.

Essential Functions:

• Facility Systems Leadership & Oversight- Lead a high-performing facilities team, providing coaching, development, and tactical direction. Define engineering standards, best technical practices, and system documentation to ensure consistent and compliant operation. Partner with Manufacturing, Quality, Validation, EHS, Supply Chain, and other cross-functional teams to support production goals.
• Engineering Opex Management- Develop and manage the multi- site maintenance budget and control spending. Oversee all maintenance projects, ensuring delivery on schedule, within maintenance budget, and in compliance with internal and regulatory expectations. Provide technical review and approval for engineering changes, URS, drawings, commissioning, and qualification documentation. Manage vendors, contractors, and service providers to ensure safe and compliant execution of maintenance tasks.
• Facilities & Utilities Management- Oversee the design, operation, and maintenance of all site facilities, utilities, HVAC systems, cleanrooms, water systems, compressed gases, electrical distribution, and building infrastructure. Ensure all critical systems comply with cGMP, OSHA, FDA, and environmental regulatory requirements. Establish and maintain preventive and predictive maintenance programs to maximize equipment uptime and overall facility reliability. Direct response to facility emergencies, system failures, and unplanned downtime to ensure minimal disruption to operations.
• Continuous Improvement & Operational Excellence- Apply Lean, Six Sigma and reliability engineering methodologies to optimize assets and reduce downtime. Identify and execute energy optimization, sustainability measures, and automation-enhanced efficiency strategies. Support digital transformation initiatives including paperless systems, automated reporting, and data-driven decision-making.
• Automation, Controls & Digital System Maintenance- Manage site automation systems, including PLCs, SCADA and BMS. Ensure automated systems remain compliant, validated, secure, and aligned with data integrity and 21 CFR Part 11 requirements. Oversee related maintenance support for manufacturing and utility equipment, including system troubleshooting, upgrades, and integration of new technologies. Collaborate with cross-functional teams to identify improvement opportunities that improve efficiency, reliability, and operational performance.
• Compliance, Quality, and Safety- Ensure all the maintenance activities meet FDA, EU, DEA, EPA, OSHA, and other regulatory standards. Act as Subject Matter Expert (SME) during regulatory inspections and internal/external audits. Maintain robust documentation systems, including engineering drawings, automation code repositories, and change control records. Reinforce a strong safety culture by implementing engineering controls, safe work methods, and contractor management procedures.

Additional Responsibilities:

• Develop and monitor departmental KPIs for maintenance, automation reliability, facility uptime, and project performance.
• Ensure lifecycle management of equipment, automation platforms, instrumentation, and system hardware.
• Provide support for optimization projects.
• Oversee contractor and vendor safety management, ensuring compliance with work permits, LOTO procedures, and site safety protocols.
• Represent the support function on cross-functional site leadership teams.
• Perform other duties as assigned to support business and operational goals.
• Local travel to Amneal facilities.