Microbiology Media & Blood Collection Tube Production Specialist

🎯 I. JOB OBJECTIVE

Organize, operate, and supervise the production of microbiological culture media and blood collection tubes to ensure:

• Stable product quality in compliance with technical specifications (pH level, volume, clarity, sterility, vacuum pressure, sealing integrity).
• Compliance with GMP, ISO 13485, ISO 14644, biosafety, and cleanroom hygiene standards.
• Ensuring production output, minimizing material loss, and maintaining raw material traceability.

⚙️ II. KEY RESPONSIBILITIES

1. Microbiological Media Preparation

• Prepare, weigh, and dissolve ingredients according to the Batch Record.
• Adjust pH, clarity, volume, and color in accordance with SOPs and product specifications (TSA, SDA, MacConkey, etc.).
• Monitor and record parameters such as temperature, processing time, mixing speed, and pressure throughout production.
• Coordinate with QC to perform sterility testing and growth promotion testing prior to filling.

2. Filling, Sealing, and Sterilization

• Operate semi-automatic or automatic filling systems for:
• Petri dishes
• Test tubes
• Plastic or glass bottles
• Inspect volume, sealing integrity, clarity, labeling, and QR codes according to regulations.
• Maintain cleanroom sanitation (ISO Class 7–8) before and after each production shift.
• Perform Autoclave sterilization or VHP (Hydrogen Peroxide Sterilization) according to validated procedures.

3. Blood Collection Tube and Test Tube Production

• Prepare raw materials including plastic tubes, caps, rubber stoppers, coating adhesives, and additives (EDTA, Heparin, Clot Activator).
• Measure and prepare additive solutions according to GMP guidelines.
• Operate production lines including spraying, drying, vacuuming, labeling, and packaging.
• Monitor technical specifications:
• Vacuum level
• Cap sealing integrity and leakage prevention
• Coating uniformity / anticoagulant distribution
• Record batch records, lot numbers, production time, and operator information.

4. Hygiene and Biosafety Control

• Ensure production areas meet environmental requirements (pressure differential, cleanliness level, particle count, microbiological control).
• Implement 5S standards and clean equipment, tools, floors, FFU units, and workstations according to checklists.
• Wear appropriate cleanroom garments, masks, gloves, caps, and anti-static footwear.
• Report deviations or abnormalities in products to QA/QC.

5. Documentation, Equipment, and Material Management

• Maintain and update Batch Records, equipment logbooks, inspection reports, and NCR records (if any).
• Monitor raw material and tool inventory and report actual consumption for production planning.
• Propose preventive maintenance schedules for mixing equipment, filling systems, drying machines, and vacuum systems.

Education:

Intermediate Diploma / College / University degree in Chemistry, Biology, Microbiology, Medical Equipment Engineering, or related fields.

Experience:

Preferably at least 1 year of experience in microbiological media production, medical solution manufacturing, or blood collection tube / laboratory tube production lines.

Professional Knowledge:

Understanding of GMP, GLP, ISO 13485 standards, aseptic techniques, vacuum technology, filling processes, and sterilization procedures.

Skills:

Ability to work in a cleanroom environment, operate production equipment, maintain documentation in compliance with GLP standards, and work effectively in a team.

Personal Attributes:

Careful, honest, diligent, compliant with procedures, and capable of maintaining confidentiality of formulation processes.

Salary: 8 - 12 million