Maintenance Engineer

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

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.

Qualifications

Education

• Bachelor's Degree (BA/BS) Engineering, Pharmaceutics, Industrial Pharmacy, or related field. - Required
• Master's 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.

About Us

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.