Maintenance Engineer — GMP Equipment Reliability

RXinsider LTD.

Piscataway Township (NJ)

On-site

USD 80,000 - 95,000

Full time

14 days+

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Job summary

Amneal is seeking a Maintenance Engineer to own the preventive and corrective maintenance, troubleshooting, and continuous improvement of manufacturing equipment used in oral solid dosage and transdermal systems, including birth control patches.

You will diagnose complex failures across mechanical, electrical, pneumatic, hydraulic, and automation systems, lead installation, qualification (IQ/OQ/PQ), and ensure GMP compliance and thorough documentation.

Qualifications

Bachelor's degree in Engineering, Pharmaceutics, Industrial Pharmacy, or related field (required).
Master's degree in Engineering, Pharmaceutics, Industrial Pharmacy, or related field (preferred).
3+ years in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.

Responsibilities

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 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.