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IVD Reagent Manufacturing Specialist - Job Opportunity at BGI Health (HK) Company Limited

Hong Kong, HK
Full-time
Mid-level
Posted: May 19, 2025
On-site
HKD 300,000 - 450,000 per year based on Hong Kong market rates for specialized medical device manufacturing roles

Benefits

Healthcare industry exposure and professional development
Clean room environment training and certification opportunities
Professional development in ISO 13485 and GMP standards
Technical skills advancement in medical device manufacturing

Key Responsibilities

Lead ISO 13485 compliant manufacturing processes for medical diagnostic reagents
Execute precise material verification and quality control procedures
Manage controlled environment production operations including compounding and packaging
Maintain and calibrate specialized production equipment
Document and validate manufacturing processes through detailed batch records
Participate in continuous improvement and training programs

Requirements

Education

College degree or higher, preferably in Biology, Medicine, Chemistry, or related fields

Experience

Prior experience with GMP/ISO 13485 preferred

Required Skills

Quality standards compliance SOP adherence Effective communication Team coordination Detail orientation Execution capabilities Cleanroom management Medical device regulations knowledge

Certifications

ISO 13485 familiarity GMP knowledge
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Sauge AI Market Intelligence

Industry Trends

The IVD market is experiencing rapid growth due to increased demand for diagnostic testing, particularly following global health events. The Asia-Pacific region is becoming a major hub for IVD manufacturing, with significant investment in automated production processes. Regulatory requirements are becoming more stringent, particularly in quality control and documentation requirements for medical device manufacturing

Role Significance

Typically part of a 5-15 person manufacturing team in a structured production environment
Mid-level technical specialist role with significant responsibility for quality-critical manufacturing processes

Key Projects

Implementation of new product manufacturing protocols Quality system optimization initiatives Production efficiency improvement projects Equipment calibration and validation programs

Success Factors

Deep understanding of ISO 13485 and GMP requirements Exceptional attention to detail in following manufacturing protocols Strong documentation and record-keeping practices Ability to work effectively in controlled environments Quick problem-solving capabilities in production scenarios

Market Demand

High demand with steady growth projection due to expanding healthcare diagnostics market and increasing quality control requirements in medical device manufacturing

Important Skills

Critical Skills

Quality system compliance - Essential for maintaining ISO 13485 certification and product reliability Technical manufacturing expertise - Core to successful product production Documentation accuracy - Critical for regulatory compliance and product traceability

Beneficial Skills

Project management capabilities - Valuable for process improvement initiatives Statistical process control knowledge - Important for manufacturing optimization Automation system familiarity - Increasingly important as manufacturing processes evolve

Unique Aspects

Opportunity to work with advanced IVD manufacturing processes
Exposure to international quality standards and regulatory requirements
Position at the intersection of biotechnology and medical device manufacturing

Career Growth

2-3 years in role before advancement opportunities, depending on performance and business growth

Potential Next Roles

Senior Manufacturing Specialist Quality Assurance Manager Production Supervisor Manufacturing Process Developer Validation Specialist

Company Overview

BGI Health (HK) Company Limited

BGI Health is a significant player in the genomics and diagnostics industry, known for advanced biotechnology solutions and medical diagnostic products

Leading position in Asian biotech market with strong presence in diagnostic testing and reagent manufacturing
Strategic location in Hong Kong serves as a gateway to both Asian and global markets
Professional environment with strong emphasis on quality standards and technical excellence
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