Responsibities
- Manage and maintain the validated status of the EAMS maintenance management system in collaboration with the QA team, Automation Information team, E/I maintenance team, and vendors for database, software, and hardware validation.
- Supervise a team of Calibration/E&I Technicians to conduct calibration and maintenance (CAL, COR, and repairs) in line with procedures, good engineering practices, and cGMP.
- Plan and schedule daily instrument calibration and maintenance activities to support smooth production operations.
- Develop and optimize instrument calibration and maintenance programs to enhance reliability and control; review and modify PM Calibration processes as needed.
- Serve as System Administrator/SuperUser for EAMS applications, conducting training for new users and ensuring effective utilization for compliance with cGMP.
- Maintain data integrity and accuracy within the EAMS system, ensuring quality compliance.
- Support financial objectives by preparing and managing the annual maintenance budget, monitoring variances, and initiating corrective actions for instrumentation and repairs.
- Lead or participate in continuous improvement initiatives and investigations (IRS/QAR).
- Manage calibration SOPs by creating, reviewing, optimizing, and training the calibration team on relevant procedures.
- Execute and manage system modifications in compliance with cGMP and good maintenance practices.
- Monitor instrument performance, track breakdowns and failures, and analyze instrument history to guide maintenance focus.
- Generate and provide reports on instrument maintenance work and PM statistics to track operational performance.
- Coordinate shutdown and maintenance activities with supervisors, engineers, production, and MRO teams, ensuring cost-effective execution of annual PM plans.
- Maintain a compliant calibration documentation system for fast retrieval and audit readiness.
- Enhance maintenance processes by working on Global Reliability Program/Preventive Maintenance Optimization activities with relevant teams.
- Update Key Performance Index (KPI) metrics in collaboration with E/I supervisors and maintenance planners.
- Liaise with production teams on tech transfers, commissioning, and improvement projects, addressing instrument hardware modifications.
- Foster collaboration with E/I, Automation, Production, and vendors to resolve operational issues effectively.
- Support special or urgent projects, ensuring timely delivery within budget constraints.
- Ensure safety and cleanliness in all work areas under responsibility.
- Train and coach team members through on-the-job training (OJT) and skill-building activities.
- Participate in IMEx Process Centric Team Tier 1 meetings to address priority engineering issues and develop TPM-OPC checklists, training operations teams accordingly.
- Complete all assigned training promptly to ensure readiness for work execution.
- Contribute to team goals by achieving desired results and KPIs.
Requirements
- Degree/Diploma in Engineering or related qualifications with a minimum of 10 years of experience in pharmaceutical, chemical, or petrochemical industries.
- Proficient in CMS application, cGMP, GMI strategies, and PMO concepts.
- Knowledgeable in Reliability Maintenance, Right First Time techniques, and performance-based management.
- Skilled in managing multiple projects concurrently, with demonstrated project management expertise.
- Proven capability to thrive in complex, matrixed environments and handle ambiguity effectively.
- Excellent written and verbal communication, with clarity and conciseness.
- In-depth knowledge of cGMP and regulatory requirements for instrument validation.
- Detail-oriented with excellent interpersonal skills and a commitment to delivering quality output.
- Proven teamwork abilities, customer focus, and dedication to continuous improvement.
- Effective at collaborating across functional teams and multiple organizational levels.
Tan Cheu Hoon, Fenny EA License No.: 02C3423 Personnel Registration No.: R22105896
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