Manufacturing Associate

Company Overview

Vela Diagnostics provides innovative diagnostic workflows for disease screening, diagnosis, and monitoring. Serving hospitals, labs, and research, they optimize processes and support medical decisions with standardized test menus and expert professionals.

Job Summary

This position is part of a driven team that performs In-Vitro Diagnostics Assay production via various molecular manufacturing techniques. Activities conducted would be required to comply with industrial and regulatory requirements. The successful candidate will be based in Singapore and reports to the manufacturing team.

Responsibilities

1. Perform activities related to manufacturing of products/finished goods to support manufacturing schedule. These include but not limited to:

• Bulk Formulation at Microliter (uL) and Milliliter (ml) levels in a laboratory environment
• Tubes / Bottles / Plates dispensing via automated and manual processes
• Printing, Labeling, Kit Assembling and Packing of products.

2. Ensure daily/monthly production targets are achieved with products manufactured according to established SOPs equipped with knowledge of upstream and downstream processes.
3. Ensure Manufacturing Yield/Defect Rate targets are achieved via proper handling of goods at the raw materials, semi-finished goods and finished goods level.

4. Ensure batch records are maintained according to ISO standards.

5. Ensure daily maintenance work in Manufacturing floor, including waste disposal, equipment maintenance, and cleanliness maintenance are completed.

6. Participate and collaborate with quality in root cause analysisactivity on non-conforming incident. Recommend and implement corrective and preventive action.

7. Involved in quality and safety risk assessment, audits, biosafety, and emergency response.

8. Inventory control of reagents and supplies via ERP and non-ERP systems.

9. Author deviation, reports, and documentations where necessary.

10. Participate in method transfer and process validation.

11. Collaborate with cross-functional teams (e.g. Quality, PT, R&D, Supply Chain and Quality Assurance) on product transfer and process improvement projects.

12. Author and improve MWI and MFM.

13. Other duties as assigned.

Preferred competencies and qualifications

• Bachelor’s Degree or Diploma in Life Sciences or related field; Higher NITEC with at least 2 years relevant experience considered
• 0-6 years hands-on experience in bioprocess or biomedical device manufacturing; experience in IVD field is a plus
• Knowledge of manufacturing documents including Manufacturing Work Instructions, Batch Records, and safety/cGMP work instructions
• Familiarity with ISO13485 and cGMP standards is advantageous
• Working knowledge of ERP systems (SAP) and document control software is an asset
• Strong organizational skills to manage multiple tasks within tight timelines with attention to detail
• Effective communication skills and commitment to teamwork
• Skilled in problem solving and exercising sound judgment based on accurate and timely analysis
• Highly motivated to learn, adapt, and grow in a fast-paced environment
• Demonstrates integrity, dependability, urgency, and results orientation with willingness to put in extra effort to achieve goals