Maintenance Engineer

Socket.dev; Piscataway Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Amneal is seeking a Maintenance Engineer to own maintenance, troubleshooting, and continuous improvement of manufacturing equipment. You will support oral solid dosage forms and transdermal systems, including birth control patches, while ensuring cGMP compliance and safe operation.

Responsibilities include developing preventive maintenance programs, diagnosing electrical, mechanical, and automation issues, coordinating IQ/OQ/PQ validation activities with validation and quality teams, and

Qualifications

• Maintenance engineering experience with preventive and corrective maintenance programs.
• Ability to diagnose mechanical, electrical, pneumatic, hydraulic and automation failures.
• Experience with GMP/cGMP compliance and equipment history documentation.
• Experience with IQ/OQ/PQ activities and validation processes.
• Strong collaboration across production, quality, engineering, and EHS.

Responsibilities

• Develop and optimize preventive and corrective maintenance programs to maximize uptime.
• Diagnose and resolve complex equipment failures across multiple systems independently.
• Lead maintenance, troubleshooting, and repair of tablet presses, coaters, mixers, dryers, and packaging lines.
• Document maintenance activities and equipment history in GMP-compliant systems.
• Support CAPA related to equipment failures and participate in RCA.
• Coordinate with validation and quality teams for IQ/OQ/PQ activities.

Skills

Maintenance engineering

Troubleshooting

Mechanical aptitude

Electrical knowledge

Regulatory compliance

Tools

Blue Mountain Regulatory software

Job description

Description:

The Maintenance Engineer will take ownership in all the maintenance, troubleshooting, and continuous improvement of manufacturing equipment and maintenance activities. They play a crucial part in ensuring smooth production of oral solid dosage forms and transdermal systems, including birth control patches. This role demands strong technical expertise, leadership in troubleshooting, and collaboration across departments to ensure operational excellence, equipment reliability, and compliance with cGMP standards.

Essential Functions:

• Develop, implement, and optimize preventive and corrective maintenance programs to maximize equipment uptime and reliability.
• Diagnose and resolve complex mechanical, electrical, pneumatic, hydraulic, and automation-related failures independently.
• Lead the maintenance, troubleshooting, and repair of sophisticated manufacturing equipment including tablet presses, coaters, mixers, dryers, slitters, packaging machines, and utilities.
• Manage and ensure accurate documentation of maintenance activities, maintenance plans, and equipment history within Blue Mountain Regulatory software adhering strictly to GMP and regulatory requirements.
• Lead or assist in equipment installation, qualification, and validation (IQ/OQ/PQ) activities, working closely with validation and quality teams.
• Support root cause analysis (RCA) and lead implementation of corrective and preventive actions (CAPA) related to equipment failures.

Additional Responsibilities:

• Collaborate closely with production, quality assurance, engineering, and EHS teams to support seamless manufacturing operations.
• Manage external contractors and vendors, ensuring adherence to safety and regulatory standards.
• Maintain spare parts inventory levels and suggest reordering as needed.
• Ensure compliance with all health, safety, and environmental standards and company policies.
• Identify and implement continuous improvement initiatives related to equipment reliability, efficiency, and safety.

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.