Job Description
Job Summary
We are seeking a skilled and proactive Maintenance Engineer with experience in the oral solid dosage (OSD) pharmaceutical industry . The ideal candidate will be responsible for ensuring reliable operation, maintenance, and continuous improvement of manufacturing equipment and facility systems to support safe, compliant, and efficient production.
Key Responsibilities
- Perform preventive, predictive, and corrective maintenance on solid oral dosage equipment, including:
- Blenders, granulators, mills.
- Tablet presses and capsule fillers
- Coating machines.
- Packaging lines (bottle, blister, cartoners)
- Troubleshoot mechanical, electrical, pneumatic, and automation issues to minimize downtime.
- Support equipment installation, commissioning, qualification (IQ/OQ), and validation activities.
- Maintain accurate maintenance records, work orders, and equipment logs in the CMMS system.
- Ensure all maintenance activities comply with cGMP, safety, and regulatory requirements.
- Collaborate with Production, Quality, and Engineering teams to resolve equipment-related issues.
- Participate in root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
- Identify opportunities for equipment upgrades, reliability improvements, and process optimization.
- Support audits, inspections, and documentation requests from QA and regulatory bodies.
- Ensure spare parts inventory is maintained and managed effectively.
Qualifications
- Bachelor’s degree in Mechanical, Electrical, Industrial, or related Engineering field (or equivalent experience).
- 4+ years of maintenance experience in a pharmaceutical oral solid dosage manufacturing environment.
- Strong understanding of cGMP, FDA, and safety regulations.
- Hands-on experience with tablet compression, encapsulation, granulation, and coating equipment.
- Ability to read mechanical drawings, electrical schematics, and equipment manuals.
- Experience with CMMS systems and maintenance documentation.
- Strong troubleshooting, analytical, and problem-solving skills.
- Ability to work independently and in cross-functional teams.
Preferred Skills
- Experience with automation systems (PLC, HMI, SCADA).
- Knowledge of HVAC, compressed air, and utility systems.
- Familiarity with lean manufacturing and reliability engineering principles
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