Maintenance Engineer

The Maintenance Engineer will take ownership in all the maintenance, troubleshooting, and continuous improvement of manufacturing equipment and maintenance activities to ensure smooth production of oral solid dosage forms and transdermal systems (including birth control patches) in compliance with cGMP.

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 maintenance, troubleshooting, and repair of manufacturing equipment including tablet presses, coaters, mixers, dryers, slitters, packaging machines, and utilities.
- Maintain accurate documentation of maintenance activities, plans, and equipment history in Blue Mountain Regulatory software per GMP/regulatory requirements.
- Lead or assist with equipment installation, qualification, and validation (IQ/OQ/PQ) with validation and quality teams.
- Support root cause analysis (RCA) and lead corrective and preventive actions (CAPA) for equipment failures.

Additional Responsibilities:
- Collaborate with production, QA, engineering, and EHS teams.
- Manage external contractors and vendors to meet safety and regulatory standards.
- Maintain spare parts inventory and recommend reordering.
- Ensure compliance with health, safety, and environmental standards and company policies.
- Identify and implement continuous improvement initiatives for equipment reliability, efficiency, and safety.

Qualifications:
- Education: Bachelor’s (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field (Required); Master’s (MS/MA) in related field (Preferred).
- Experience: 3+ years in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.

Compensation/Benefits:
- Base salary: $80,000–$95,000 per year.