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A leading biopharmaceutical company in Gelang Patah, Malaysia is seeking a Mechanical Fitter to perform routine maintenance on mechanical systems in compliance with cGMP standards. Responsibilities include troubleshooting mechanical issues, assisting in installations, and maintaining documentation in SAP. The ideal candidate will have a diploma/degree in engineering and 2–5 years of relevant experience. Strong mechanical aptitude and teamwork skills are essential for this role.
Perform routine preventive maintenance of mechanical systems (pumps, agitators, compressors, HVAC, utility equipment).
Respond promptly to equipment breakdowns and troubleshoot issues to minimize downtime.
Assist in installation, alignment, and commissioning of new machinery and equipment.
Interpret and work from engineering drawings and technical manuals.
Compliance & Documentation
Maintain maintenance records in SAP as per cGMP requirements.
Ensure adherence to SOPs, safety protocols, and regulatory guidelines.
Utility Support
Support calibration of mechanical instruments and utility systems (steam, water, air).
Participate in root cause analysis and corrective action implementation.
Strong mechanical aptitude and troubleshooting skills.
Minimum Knowledge of cGMP, safety standards, and pharmaceutical compliance.
Ability to read technical drawings and use precision tools.
Familiarity with pumps, gearboxes, valves, and rotating equipment.
Personal Attributes:
Attention to detail and commitment to hygiene standards.
Ability to work in shifts and respond to emergencies.
Good communication and teamwork skills.
Preferred Qualification & Experiences:
Diploma / Degree in all Engineering courses.
2–5 years in pharmaceutical or food or medical devices or biotech plant maintenance.
Exposure to cleanroom environments and sterile manufacturing equipment will be added advantage.