Lead Maintenance Engineer – GMP Pharma Ops

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

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