KEY ACCOUNTABILITIES:
The Maintenance Technician/Engineer is primarily responsible for performing routine preventive maintenance, predictive maintenance, unplanned repairs, and daily inspections on DP-area equipment, along with other equipment lifecycle management tasks assigned by superior, to ensure stable and reliable equipment operation.
Project Construction, CQV and Startup Phase:
• Support installation, commissioning, equipment start-up activities, and execution of FAT/SAT and IOQ.
• Support commissioning test, punch list closures, deviation/variations resolutions, and change controls related to packing equipment.
• Support for start-up batches, technical troubleshooting, and first-of-a-kind process runs.
• Support technical clarifications, engineering changes, and ensure documentation completion.
Operational Phase:
• Responsible for performing daily preventive maintenance, predictive maintenance, and routine inspections on DP-area equipment, ensuring scheduled maintenance is completed as planned.
• Responsible for resolving unplanned equipment failures with prioritized rapid response to minimize downtime; coordinate remote assistance with vendors when required.
• Troubleshoot technical issues during equipment operation, document Breakdown Analysis (BDA) and lessons learned for equipment-related problems.
• Provide technical support during internal audits, FDA/EMA/HSA inspections, and client audits.
• Support deviation investigations, CAPA development, change control, periodic reviews, and risk assessments (HAZOP, FMEA, CMMS updates).
• Ensure timely and accurate updates of system documentation (SOPs, Maximo job plans, equipment files).
• Continuously identify and eliminate potential audit risks to achieve audit readiness as a routine practice.
• Other tasks assigned by superior.
REQUIREMENTS:
• Must be flexible to work in a 24/7 shift rotation.
• New graduates with a bachelor's degree or higher, 2 years or above relevant maintenance experience in pharmaceutical manufacturing is preferred.
• Good knowledge of GMP requirements and international standards.
• Good analytical, troubleshooting capabilities.
• Proficiency in English (written and spoken).
EDUCATION:
• Bachelor's degree in Environmental, Electrical, mechanical engineering or equivalent.
OTHER SKILLS, ABILITIES & EXPERIENCE:
• Good MS Office, AutoCAD skills,
• Familiar with P&ID diagrams, electrical schematics, and mechanical drawings;
