Technical Specialist – Biologics

Job Purpose Support 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