Job Description

Facility Support: Ensures general facility maintenance and operational effectiveness throughout the manufacturing facility spaces, in keeping with regulatory and company guidelines.Maintenance: Applies skill in the maintenance and operation of facility systems (Process water system, HVAC system, clean room system, boiler system, incoming power, water supply, air compressed system, building maintenance, fire protection system, sanitary system and janitorial service) to ensure ongoing optimum performance, in compliance in EHS and other applicable quality and regulatory guidelines.Key Responsibilities:

• Assigns scheduled and unscheduled preventive maintenance routines to facilities Technicians, supervise and verifies execution.
• Apply in-depth knowledge and technical proficiency in operation and maintenance of facilities systems to ensure successful outcomes, devise complex process changes, and ensure knowledge transfer to other levels of technicians.
• Lead and manage minor facilities projects. Managing of contractor, vendor and/or consultant to develop project plan and budget if required raise CAPEX for approval. Oversee and ensure that contractor and vendor perform all tasks to specification and compliance to GxP and EHS requirement
• Check for failures in equipment and perform or supervise corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents, exception work orders (EWOs), Equipment Non-conformance Reports (ER/CMs), and Out of Tolerance (OOTs).
• Troubleshoot, as well as anticipate issues, and propose solutions to limit downtime and keep production on schedule
• Analyze predictive inspection data of critical facilities systems include clean room system with engineer to determine predictive maintenance action to prevent premature system breakdown
• Collaborate with Quality and Engineering to evaluate existing processes and identify opportunities for improvement and optimal operations.
• Provide training, coaching, guidance, and information to lower level technicians as requested and needed.
• Assist engineer performing validation on facilities systems include clean room system
• Review and enhance effectiveness of Preventive Maintenance, TPM, continuous improvement and calibration with engineer.
• Establish equipment spare parts list of facilities system include clean room system
• Manage facilities asset list. Review engineer and manager on new and disposed asset resolutio
• Other incidental duties (e.g. occasional photo copying or deliveries)

• Bachelors Degree or equivalent in Mechanical/Electronic/Electricity Engineering (or relevant) Degree from a recognized institution with 7 years of related experience.
• Working knowledge of electrical, mechanical, lubrication, pneumatic, boiler and/or autoclave required

• Demonstrated ability to lead teams, coach others, and transfer knowledge
• Strong English language skills, including reading, comprehending, speaking and writing, and good communication skills
• Proficient computer skills, including MS Office and Maximo
• Extensive knowledge of routine preventive maintenance of Facilities system.
• In-depth knowledge in HVAC system, Electrical system, Clean room system, RO water system, Steam boiler system and Compressed air system
• Full knowledge of GxP, Quality and EHS practices
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work independently, and provide guidance, training, and assignments to lower-level technicians
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Project management knowledge and budgeting
• Must be able to work independently including formulating work instructions and providing guidance and training to lower-level employees
• Ability to read and understand blueprints, sketches, layouts, wiring diagrams, drawings and specifications

Edwards Lifesciences