� Roles & Responsibilities:
- Execute and optimize planned Preventive Maintenance (PM) and perform rapid Breakdown/Corrective maintenance specifically on Rommelag Blow-Fill-Seal equipment.
- Troubleshoot and resolve complex mechanical, electrical, pneumatic, and hydraulic issues (including extrusion, molding, filling, and CIP/SIP systems).
- Lead Root Cause Analysis (RCA) for major equipment breakdowns and implement effective Corrective and Preventive Actions (CAPA).
- Ensure all maintenance activities, logs, and reports are documented accurately in strict compliance with cGMP, SFDA regulations, and internal SOPs.
- Manage and monitor the spare parts inventory for BFS machines to ensure the availability of critical components and minimize downtime.
- Lead format/mold changeovers, machine setups, and precise adjustments to ensure optimal production efficiency and product quality.
- Support and participate in equipment validation, calibration, and qualification processes (IQ, OQ, PQ) for any machine upgrades.
- Train and mentor junior technicians and machine operators on best practices for Rommelag machine handling and basic troubleshooting.
- Strictly adhere to cleanroom/sterile area protocols, Health & Safety guidelines, and LOTO (Lockout/Tagout) procedures during all interventions.
� Desired Candidate Profile & Requirements:
- Education: Bachelor’s degree in Mechanical, Electrical, Mechatronics Engineering, or a closely related field.
- Experience: 5 to 10 years of proven, hands-on experience in the pharmaceutical industry, specifically with maintaining, troubleshooting, and overhauling Rommelag BFS systems.
- Technical Skills: Deep knowledge of mechanical assemblies, fluid dynamics, PLC logic basics, and pneumatic/hydraulic systems within BFS machines.
- GMP & Sterile Expertise: Strong understanding of cGMP, aseptic processing, and cleanroom behaviors (ISO classifications). Experience with CIP (Clean-in-Place) and SIP (Sterilization-in-Place) cycles is essential.
- Problem-Solving: Proven ability to work under pressure, quickly diagnose mechanical/electrical faults, and apply effective RCA techniques.
- Language: Fluency in English (spoken and written) for effective communication and documentation.
