Manufacturing Engineer – GMP & Process Improvement

Standard BioTools Inc.

Hong Kong

On-site

HKD 300,000 - 420,000

Full time

14 days+

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Job summary

Standard BioTools Inc. in Hong Kong seeks a Manufacturing Associate to support manufacturing and engineering development for Integrated Fluidic Circuit (IFC) products, driving process improvements, quality compliance, and operational efficiency.

You will collaborate with manufacturing and engineering teams to assess readiness for new products and equipment, analyze performance data, and implement actions that reduce costs and increase yield while maintaining GMP/GDP standards in a cleanroom

Qualifications

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Electronics Engineering, or related field with 1–3 years relevant experience.
Diploma in Engineering or related technical field with minimum 5 years relevant manufacturing experience.
Ability to assess manufacturing needs, initiate independent actions, and apply engineering and quality improvement techniques.
Proficiency in SPC, DOE, and process data analysis.
Knowledge of Excel formulas/macros, statistical tools, and Power BI.
Willingness to work in a clean room environment for extended periods.
Awareness of ISO 13485, GMP, or regulated manufacturing environments.

Responsibilities

Initiate and execute manufacturing workflow, procedure, and quality control improvements to reduce costs, shorten cycle times, increase yield, enhance workforce skills, and ensure compliance with quality, safety, and health standards
Support implementation of new products, processes, and equipment by assessing manufacturing readiness, initiating necessary actions, tracking progress, escalating issues, and communicating updates
Ensure manufacturing compliance with quality systems by identifying process discrepancies and specification deviations, supporting readiness for quality system implementation, and updating SOPs, WIs, and work orders per GMP and GDP requirements
Maintain and enhance manufacturing and QC performance reports to measure key metrics such as start, pack, WIP, cycle time, yield, and cost
Utilize ERP systems (Visual Manufacturing, D365, SAP) to analyze operational performance data and support planners in product costing and BOM setup
Model equipment capacities, identify operational bottlenecks, and maintain capacity tables to optimize manufacturing strategies in collaboration with supervisors and managers
Support purchasing of IFC raw materials by coordinating with Purchasing and Process teams to ensure supply quality and availability
Assist in manufacturing job training by supporting training documentation and helping engineers and manufacturing staff conduct job training sessions
Perform additional duties as assigned by management to support business and operational needs