Responsibilities:
- Reporting to Account Manager
- Build relation with client
- Lead a team of assistant engineers and provides technical support to operations team in solving equipment maintenance related issues.
- Ensures that all facility equipment is well maintained, no overdue PM and calibration, equipment down time is minimized, equipment utilization is optimized and appropriate safety procedures are carried out.
- Conducts root cause analysis on process and equipment maintenance related issues and ensures that corrective and preventive actions are successfully implemented within the given timeframe.
- Involves in plant assets management, calibration supplier control, calibration and preventive maintenance scheduling, job plans and work order tracking.
- Ensures that all equipment spares and consumable parts are adequate to support manufacturing operations.
- Lead and drives Lean, Six Sigma, Total Productive Maintenance, Business Excellent projects to minimize waste, reduce product defects, cost reductions and equipment maintenance enhancement.
- Manages projects and supports equipment installation qualification and revalidation activities.
- Ensures that technicians are trained and proficiently supporting manufacturing according to updated SOPs and adhere to GMP, GDP and safety requirements.
- Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment
Quality Management System
- Adherence to cGMPs is required at all times when working on site.
- Practice good sanitation and health habits.
- Ensuring adherence to governing SOPs and quality policies (JLL or Client) where relevant
- Proactively ensure any quality issues, incidents or best practices are reported and shared
- Ensure timely completion of all quality training as plan
- Support GMP incident root cause investigations and CAPA creation/ completion as necessary
- Ensure all infrastructure and compliance documentation for the systems is up-to-date (e.g. maintenance logs, drawings and single-line diagrams)
- Ensure all Work Order activities are documented in time achieved periodically
- Ensure those subcontractors under supervision understand compliance requirements such as GxP requirements and Change Control
Requirement:
- Min Diploma/ Degree with at least 3 years of experience in similar function
- Strong technical background on equipment maintenance, equipment enhancement and troubleshooting
- Experience in equipment and instrumentation
- Familiar with Clean room requirements
- Experience in HVAC system
- Substantial understanding of processes and equipment used in assigned work. Knowledge in continuous improvement to improve/streamline process and equipment
- Basic understanding of statistical techniques
- Experience in project management
- Strong problem-solving, organizational, analytical and critical thinking skills
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Good leadership skills and ability to influence change
- Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or project.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations