Role Summary
Maintenance Engineer responsible for maintenance, troubleshooting, and continuous improvement of manufacturing equipment to ensure operational excellence, equipment reliability, and regulatory compliance.
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 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.
Qualifications
- Education:
- Required: Bachelors Degree (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
- Preferred: Master Degree (MS/MA) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
- Experience:
- 3 years or more in Engineering, Pharmaceutics, Industrial Pharmacy, or related field.
Skills
- Technical troubleshooting across mechanical, electrical, pneumatic, hydraulic, and automation systems.
- Documentation and regulatory compliance (GMP).
- Equipment installation, qualification (IQ/OQ/PQ), and validation processes.
- Root cause analysis and CAPA implementation.
Education
- Bachelors Degree (BA/BS) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field — Required
- Master Degree (MS/MA) in Engineering, Pharmaceutics, Industrial Pharmacy, or related field — Preferred
Additional Requirements