Amneal Pharmaceuticals
Overview
The Maintenance Engineer will own maintenance, troubleshooting, and continuous improvement of manufacturing equipment and maintenance activities. They contribute to smooth production of oral solid dosage forms and transdermal systems, including birth control patches. The role requires strong technical expertise, leadership in troubleshooting, and cross-functional collaboration 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 to GMP and regulatory requirements. Lead or assist in equipment installation, qualification, and validation (IQ/OQ/PQ), working 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 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 health, safety, 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) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field — Required Master’s Degree (MS/MA) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field — Preferred Experience 3 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
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The Maintenance Engineer will own maintenance, troubleshooting, and continuous improvement of manufacturing equipment and maintenance activities. They contribute to smooth production of oral solid dosage forms and transdermal systems, including birth control patches. The role requires strong technical expertise, leadership in troubleshooting, and cross-functional collaboration 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 to GMP and regulatory requirements. Lead or assist in equipment installation, qualification, and validation (IQ/OQ/PQ), working 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 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 health, safety, 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) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field — Required Master’s Degree (MS/MA) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field — Preferred Experience 3 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
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