Pharma Maintenance Engineer – Equipment Reliability

RXinsider LTD.; Piscataway Township (NJ); On-site; USD 80,000 - 95,000; Full time

Job summary

Amneal is seeking a Maintenance Engineer to own maintenance, troubleshooting, and continuous improvement of manufacturing equipment for oral solid dosage forms and transdermal systems, ensuring cGMP compliance.

Responsibilities include developing maintenance programs, diagnosing complex failures, leading IQ/OQ/PQ activities, CAPA, and collaborating with QA, engineering, and EHS teams. Manage contractors, inventory, and documentation to support reliable operations.

Qualifications

• Bachelor’s Degree in Engineering, Pharmaceutics, Industrial Pharmacy, or related field required.
• Master’s degree preferred.
• 3+ years in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.

Responsibilities

• Develop, implement, and optimize preventive and corrective maintenance programs.
• Diagnose and resolve mechanical, electrical, pneumatic, hydraulic, and automation failures.
• Lead maintenance and repair of tablet presses, coaters, mixers, dryers, packaging machines, and utilities.
• Document maintenance activities, plans, and history in regulatory software per GMP.
• Lead IQ/OQ/PQ activities with validation and quality teams.
• Support RCA and lead CAPA related to equipment failures.
• Collaborate with production, QA, engineering, and EHS for seamless operations.
• Manage external contractors and vendors and maintain spare parts inventory.

Skills

Preventive maintenance

Troubleshooting

CAPA

Root cause analysis

Leadership

Cross-functional collaboration

Equipment reliability

Education

Bachelor's Degree in Engineering or related field

Master's degree preferred

Tools

Blue Mountain Regulatory software

Job description

Amneal is seeking a Maintenance Engineer to own maintenance, troubleshooting, and continuous improvement of manufacturing equipment for oral solid dosage forms and transdermal systems, ensuring cGMP compliance.

Responsibilities include developing maintenance programs, diagnosing complex failures, leading IQ/OQ/PQ activities, CAPA, and collaborating with QA, engineering, and EHS teams. Manage contractors, inventory, and documentation to support reliable operations.