Essential Functions of the Job:

Review and mark-up design drawings to align capacity and function with Company strategy and provide practical and easily-maintained design. Recommend and approve preferred vendors for equipment and spares.

Selection of process equipment and instruments including consumables and spare parts.

Prepare, review and update documented User Requirement, Functional Specifications and Detailed Specifications.

Review and approve the SAT, FAT, Commissioning and Qualification Protocols. Participate in execution of SAT, FAT, Commissioning and Qualification.

Write and update the SOPs related to management of process equipment (e.g. System ID, system validation status) and provide the training to the users.

Maintain the process equipment list as the latest version if any update and prepare periodic reports of the process equipment status.

Generate the process equipment maintenance plan, and together with a Scheduler, establish the process equipment Maintenance Master Schedule.

Critically assess spare parts requirement to generate the purchase list of the safety stock. If any shortage after consumption, reorder the parts.

Support calculation of the annual maintenance budget and take actions to control expenditure within the budget.

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Bachelor degree in engineering or pharmaceutical production.

Essential Experience:

Minimum of 4 years of experience in process management within pharmaceutical or medical device industries. Or at least 8 years of industry experience in calibration in pharmaceutical, medical device, healthcare, or food industries.

Ability to push the activities moving forward according to the schedule.

Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English.

Essential Functions of the Job:

Technical Analysis: including electrical system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design (energy efficient), constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

Develop equipment/systems preventative maintenance plans including the coordination of annual contract services, ordering of replacement components/parts, and schedule coordination.

Hands-on involvement with the troubleshooting, maintenance and operation of site automation systems.

Individual will be responsible for site BAS (Building Automation System) and CMS (Central Monitoring System) operations, preventative maintenance program, planning and coordinating the annual utility system and site shutdowns.

Evaluation of site BAS (Building Automation System) and CMS (Central Monitoring System) performance through assessment of system logs, monitoring reports, and maintenance program. Develop corrective measures to improve system operational efficiency.

Provide technical assistance to site operating groups through investigations, equipment assessments, and design support.

Develop equipment/systems preventative maintenance plans including the coordination of annual contract services, ordering of replacement components/parts, and schedule coordination.

Management of building and utility control systems to ensure response to critical alarms in compliance with Maintenance and Quality Procedures. Evaluate trends and establish corrective actions to avoid repeat events.

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Bachelor in electricity & automation or related Engineering degree.

Essential Experience:

Minimum of 5 years of experience in automation system within pharmaceutical or medical device industries. Or at least 8 years of industry experience in pharmaceutical, medical device, healthcare, or food industries.

Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding technical documentation in English.

Solid experience in manufacturing industry and support equipment is essential; Working knowledge of process control systems is required.

Technical knowledge regarding the design, operation, preventative maintenance and trouble-shooting of site utilities is required.

Solid experience in Biopharma/Pharma manufacturing and support equipment is essential; Working knowledge of process control systems, building management and utility control systems (expertise with PLC hardware and SCADA computer systems) is required.