Maintenance Engineer

Role Summary

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.

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-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.
• 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

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

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