- Responsible for the day-to-day Utility & Facility Operations to ensure smooth manufacturing operation, compliance to GMP, Dexcom and Malaysia's safety/environment standards and legislative regulations.
- Support and work closely with all Plant EHS and Quality initiatives and targets.
- Responsible for the day-to-day Utilities Operations (Utilities & Facilities, Maintenance, Automation & Control) to ensure smooth manufacturing operation.
- Responsible to ensure the Utility Areas runs smoothly. Spares/consumables inventory meeting critical maintenance requirement.
- Continuously innovate operations to improve asset and resources utilization.
- Responsible for review and development of specific documentation, procedures and site change control processes for equipment and process.
- Manage the preventive maintenance and calibration program for facilities equipment.
- Participate in ad-hoc projects and perform other duties as assigned.
- Liaison Government authorities as required.
- Carry out other work or task as directed by Manager.
- Diploma or higher in Mechanical or other related qualification.
- 8+ years of industry experience.
- Broad engineering skills and experience in utility, automation, instrumentation and project management and plant start-up
- Strong understanding and experience of GMP & EHS requirements and external/internal audits
- Strong business and customer focus
- Good engineering problem solving skills, workload resource planning and prioritization skills;
- Continuous challenge and improvement current operations
- Organized and good team player, able to multi-task and work under pressure
- Knowledge on Lean Sigma tools ( 5S /Pareto /5 why /DMAIC / RCA /Fish bone analysis ) will be added advantage
- Knowledge on ISO stds for medical devices and environmental acts
Senior Facility Engineer - George Town, Malaysia - Dexcom
Description
About Dexcom
Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year revenues of $2.9B, a growth of 18% over . Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8, people worldwide.
Functional Description: Facilities
Provide engineering support to Project team on start up, commissioning, validation, IQ, OQ and PQ to completion. Responsible for the operation and maintenance of the plant utilities and facilities ensuring all manufacturing production requirements are met in terms of engineering support and utilities supplies.
Essential Duties & Responsibilities:
Required Qualifications:
Experience and Education Requirements:
Industry experience in Medical Device manufacturing in a Controlled Environment.
Greenfield experience in Medical Device and/or other regulated industry would be an added advantage.
Travel Required:
Up to 25%
Functional/Business Knowledge:
Knowledge and awareness spans all aspects of the specific functional area.
Enhances understanding and knowledge of how functional objectives support corporate objectives.
Possesses in-depth knowledge of leading best practices in area of expertise, especially knowledge in design, construction, operation and maintenance of compressed air system, chillers, cooling towers, vacuum pumps, exhaust, DI water system.
Scope:
Establishes operational objectives and work plans, and delegates assignments to team members / supporting employees.
Provides guidance and support to team members / employees.
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Requires the ability to effectively influence others and manage sensitive situations.
Judgement:
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the organization.