Overview
Maintenance Engineer BFS – Rommelag Jobs in Jeddah, Saudi Arabia at Holly Pharma
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.
Title: Maintenance Engineer BFS – Rommelag
Company: Holly Pharma
Location: Jeddah, Saudi Arabia
Category: