Technical Specialist Biologics
randstad pte. limited- Posted a month ago
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Job Description
Job PurposeSupport day-to-day cGMP biologics manufacturing operations, batch documentation, deviation investigations, and process readiness within a high-volume biopharmaceutical production facility.
Key Responsibilities
Bioprocess & Aseptic Execution: Perform upstream bioprocess activities, cell culture handling, bioreactor operations, aseptic sampling, and contamination control under strict cGMP guidelines.
GMP Documentation: Assist in authoring, revising, and executing Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and electronic batch production logs while ensuring cGMP data integrity.
Deviation & RCA Support: Support manufacturing deviation investigations by gathering operational data and participating in Root Cause Analysis (RCA) methodologies (5-Whys, Ishikawa, FMECA) to drive CAPA closure.
Process Systems & Tools: Monitor and operate DeltaV Plant Wide Control Systems (PWCS), SIMCA process monitoring software, and SAP ERP for material movements and batch execution.
Operational Excellence: Support campaign readiness, technology transfers, safety risk assessments, continuous improvement initiatives, and internal/external audit preparations.
Requirements & Qualifications
Bachelor's Degree or Diploma in Chemical Engineering, Biotechnology, Biomolecular Engineering, or a related discipline.
2 years of experience in cGMP biopharmaceutical, biologics, or cleanroom manufacturing.
Foundational knowledge of upstream bioprocessing, aseptic technique, and automated process control systems (DeltaV/SCADA).
Exposure to quality systems, deviation tracking, and cGMP data integrity principles.
- Strong technical troubleshooting, problem-solving, and cross-functional communication skills
If you are interested in the position , kindly send your CVs in to jasper.soh(@)randstad.com.sg
Please include your availability, expected salary and reason for leaving your current job
We regret that only shortlisted candidates will be contacted
EA: 94C3609 / Reg: R25154228
More Info
Key Skills
SIMCA
GMP Documentation
5-Whys
automated process control systems
