Director, Engineering (Reliability)

Merck & Co.; Piscataway Township (NJ); On-site; USD 205,000 - 236,000; Full time

Benefits offered by this job

Competitive benefits

401(k) matching

Performance-based incentive

Job summary

Amneal is seeking a Director of Reliability Engineering in New Jersey to lead a multidisciplinary maintenance organization across pharmaceutical manufacturing sites, ensuring 24/7 compliant and efficient operations.

The role requires extensive experience in facilities systems, process equipment, control systems, and utilities, with strong emphasis on cGMP, regulatory compliance, and continuous improvement initiatives.

Qualifications

• Bachelor’s Degree in Engineering/Manufacturing required; Master’s preferred.
• Extensive leadership in facilities maintenance and reliability is expected.
• Experience with cGMP, FDA, OSHA and environmental requirements is advantageous.

Responsibilities

• Facility Systems Leadership & Oversight – lead facilities team and ensure compliant operation.
• Engineering Opex Management – manage multi-site maintenance budget and ensure on-schedule delivery.
• Facilities & Utilities Management – oversee site facilities, utilities, HVAC, cleanrooms, water systems, electrical distribution.
• Continuous Improvement & Operational Excellence – apply Lean, Six Sigma and reliability methodologies.
• Automation, Controls & Digital System Maintenance – manage site automation, PLCs, SCADA, and BMS.
• Compliance, Quality, and Safety – ensure maintenance complies with FDA/EU/OSHA and manage audits.

Skills

Leadership

Facilities maintenance

Reliability engineering

Regulatory compliance

Education

Bachelor’s Degree in Engineering/Manufacturing

Master’s Degree in Engineering/Manufacturing

MBA (preferred)

Tools

SCADA

PLCs

BMS

Job description

Description

The Director, Reliability Engineering, 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 sites in the 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, control 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 operational reliability. The candidate must have exposure to FDA‑regulated environments.

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 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 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.

Education

• Bachelor’s Degree (BA/BS) in Engineering/Manufacturing – Required
• Master’s Degree (MS/MA) in Engineering/Manufacturing – Preferred
• Master’s Degree (MBA) – Accepted if undergraduate Degree is in Engineering/Manufacturing discipline. – Preferred

Experience

• 15 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 15 years of experience in Industrial Pharmacy or Engineering in lieu of the bachelor’s degree.
• 12 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field plus 12 years of experience in Industrial Pharmacy or Engineering in lieu of the master’s degree.

The salary range for this position is $205,000 – $236,000 per year. In addition, Amneal offers a short‑term incentive opportunity, such as a bonus or performance‑based award, as well as a long‑term incentive award, such as restricted stock units, with this position within the first 12 months. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to qualifications, experience, geographic location, and other relevant skills.

Amneal offers a comprehensive, flexible, and competitive benefits program for eligible positions. Benefits include above‑market, diverse and robust health and insurance options, a significant 401(k) matching contribution, and programs that support employee well‑being.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail]. Requests will be handled confidentially and in accordance with applicable laws.