1y Technical Specialist (Up to 4.2k, no exp needed, West) #HAC

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD seeks a Technical Specialist to support three pillars of manufacturing operations: Readiness, Run, and Release. You will contribute to technology transfers, process campaigns, and documentation such as Master Batch Records and Change Requests.

The role requires a degree in Biotechnology or Biomedical Science, with advantageous experience in manufacturing/QA operations and a solid understanding of manufacturing processes and equipment.

Qualifications

• Degree in Biotechnology or Biomedical Science.
• Good understanding of manufacturing processes and equipment.
• Relevant manufacturing/QA operation experience is advantageous.

Responsibilities

• Support Readiness, Run and Release activities across manufacturing operations.
• Assist technology transfers and process campaigns including MBRs, CRs, and documentation.
• Support CAPAs, deviations, audits, investigations and lot disposition during process campaigns.

Education

Bachelor's degree in Biotechnology/Biomedical Science

Job description

• The Technical Specialist will be responsible for supporting three key areas of Manufacturing operations – Readiness, Run and Release as assigned.
• Operational readiness activities for technology transfers and process campaigns include development/revision of Master Batch Records (MBRs), Change Requests (CRs), document creation/revisions, management of operational risk assessments, pre-campaign trainings and other associated tasks that are required prior to the start of process campaigns.
• Operational run activities include supporting assessments of Manufacturing deviations in DRB, managing CAPAs, tasks, CSCCs, rejected material management, participating in audits for deviation investigation topics and other associated tasks that are required during process campaigns.
• Operational release activities include leading deviation investigations and trend investigations alongside documentation of the root cause analysis, identification of appropriate Corrective and Preventive Actions (CAPAs) and product impact assessment that supports timely lot disposition.

Requirements

• Degree in Biotechnology/Biomedical Science
• Relevant manufacturing/process/QA operation experience would be advantageous
• The individual should have good understanding of manufacturing processes and operational knowledge of manufacturing equipment.