Maintenance Engineer - 2nd shift

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

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.

Education:

• Bachelors Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy, or related field. - Required
• Master Degree (MS/MA) Engineering, Pharmaceutics, Industrial Pharmacy, or related field. - Preferred

Experience:

• 3 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.

The base salary for this position ranges from $80,000 to $95,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.