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Production Technologist
2 weeks ago
**Production Technologist
**Liberte is the Talent Acquisition Partner of Mirxes.
Mirxes is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. They specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Their mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Their vision is to be the worlds leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.
**Job Summary**:
Production department is heading in all Research Use Only and In-Vitro Diagnostic product manufacturing activities under the ISO 13485 Quality management system. Our client is building capabilities in flexible manufacturing to support high mix low volume orders from both local and oversea customers. This role will be focusing on monitoring daily operational tasks according to production plan. Be the first line of decision maker on the production floor to solve problems. He/she will report to the production supervisor directly under the production department.
**Roles and Responsibilities**
- Ensure timely, accurate and quality DX/RUO production compliance to ISO 13845 and other relevant regulatory requirements
- Good hands-on experience in PCR related production activities such as buffer formulation, dispensing and kitting.
- Support process validation activities under the supervision of production supervisor (IQ, OQ, PQ, PV)
- Perform regular environmental monitoring and sanitization of facilities to upkeep facilities requirement
- Perform monitoring for process and equipment performance
- Support training new employees on production process
- Participate in the development of new manufacturing and quality control processes.
- Actively support in process improvement to increase production efficiency
- Troubleshoot equipment and process problems.
- Support out-of-specifications manufacturing investigations, change control and root cause investigations for non-conformance.
- Perform other duties as assigned.
- Willing to work in a fast-paced working environment and 12 hours rotating shift.
**Education, Skills, & Competencies**
- Bachelors degree in Engineering (Chemical/Biomedical), Biotechnology, Life Sciences or equivalent.
- Hands-on Wetlab experience
- At least 2 years of working experience in Biotech/ Medical Device manufacturing industry with knowledge of GMP/ GDP requirements.
- Experience in SAP/MES production order processing and immediately available is highly preferred.
- Background in molecular biology and experience in PCR reagent production is desired.
- Willing to work 12-hour shift, on weekends, off-shifts and overtime as required.
