IVD Manufacturing Specialist

VELA OPERATIONS SINGAPORE PTE. LTD.; Santo Niño 1st; On-site; PHP 2,485,000 - 4,142,000; Full time

Job summary

VELA OPERATIONS SINGAPORE PTE. LTD. is seeking a manufacturing specialist to perform activities related to the production of in-vitro diagnostics products in a regulated environment.

The role requires adherence to SOPs, proper documentation, and collaboration with Quality, R&D, and Supply Chain teams in Singapore. The successful candidate will operate in a fast-paced bioprocess setting, with responsibilities spanning formulation, dispensing, labeling, and batch record maintenance while ensuring

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

Responsibilities

• Perform activities related to manufacturing of products/finished goods to support manufacturing schedule
• 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
• Ensure daily/monthly production targets are achieved with products manufactured according to established SOPs equipped with knowledge of upstream and downstream processes
• Ensure Manufacturing Yield/Defect Rate targets are achieved via proper handling of goods at the raw materials, semi-finished goods and finished goods level
• Ensure batch records are maintained according to ISO standards
• Ensure daily maintenance work in Manufacturing floor, including waste disposal, equipment maintenance, and cleanliness maintenance are completed
• Participate and collaborate with quality in root cause analysisactivity on non-conforming incident. Recommend and implement corrective and preventive action
• Involved in quality and safety risk assessment, audits, biosafety, and emergency response
• Inventory control of reagents and supplies via ERP and non-ERP systems
• Author deviation, reports, and documentations where necessary
• Participate in method transfer and process validation
• Collaborate with cross-functional teams (e.g. Quality, PT, R&D, Supply Chain and Quality Assurance) on product transfer and process improvement projects
• Author and improve MWI and MFM
• Other duties as assigned

Skills

Strong organizational skills

Effective communication

Problem solving

Teamwork

Attention to detail

Education

Bachelor’s Degree or Diploma in Life Sciences

Higher NITEC with 2 years experience

Tools

ERP SAP

Document control software

Job description

VELA OPERATIONS SINGAPORE PTE. LTD. is seeking a manufacturing specialist to perform activities related to the production of in-vitro diagnostics products in a regulated environment.

The role requires adherence to SOPs, proper documentation, and collaboration with Quality, R&D, and Supply Chain teams in Singapore. The successful candidate will operate in a fast-paced bioprocess setting, with responsibilities spanning formulation, dispensing, labeling, and batch record maintenance while ensuring