Maintenance Engineer — GMP Manufacturing & Equipment Reliability

Operations; 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.

You will lead maintenance of tablet presses, coaters, mixers, dryers, and utilities, ensuring documentation, IQ/OQ/PQ activities, and CAPA execution. Collaboration with QA/validation is essential for regulatory adherence and reliability.

Qualifications

• BS/BA in engineering or related field required.
• MS/MA in engineering, pharmaceutics or related field preferred.
• Minimum 3 years in engineering or related roles.

Responsibilities

• Develop and optimize preventive and corrective maintenance programs.
• Diagnose and resolve complex mechanical, electrical, pneumatic, hydraulic, and automation failures.
• Lead maintenance and repair of tablet presses, coaters, mixers, dryers and packaging machines.
• Document maintenance activities and equipment history per GMP requirements.
• Lead IQ/OQ/PQ activities with validation and quality teams.
• Support RCA and implement CAPA related to equipment failures.

Skills

Preventive maintenance

Troubleshooting

CAPA implementation

IQ/OQ/PQ

Regulatory compliance

Maintenance planning

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering/Pharmaceutics

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.

You will lead maintenance of tablet presses, coaters, mixers, dryers, and utilities, ensuring documentation, IQ/OQ/PQ activities, and CAPA execution. Collaboration with QA/validation is essential for regulatory adherence and reliability.