Technical Specialist – GMP Biologics (1‑yr Contract)

About the role

This position supports manufacturing operations in a GMP biologics environment, covering readiness, run, and release phases. The specialist will lead investigations of deviations, non‑conformities, and other manufacturing events, ensuring timely resolution and compliance.

Key responsibilities

• Lead root‑cause investigations using RCA methods such as 5 Whys, Fishbone/Ishikawa, FMECA, and fault‑tree analysis.
• Assess product and batch impact, document findings, and determine appropriate corrective actions.
• Develop, implement, and verify CAPAs to prevent recurrence of quality issues.
• Prepare and review technical investigation reports, Master Batch Records, SOPs, change requests, and risk assessments.
• Support deviation rating at Deviation Review Boards and participate in internal and external audits.
• Collaborate with Manufacturing, MSAT, QA, QC, Engineering, Validation and other SMEs on investigations and technology transfers.
• Identify continuous‑improvement opportunities to enhance process robustness and efficiency.

Required profile

• Diploma or degree in Biotechnology, Biological Science, Chemistry, Biomedical Engineering, Chemical Engineering or related field.
• Willingness to commit to a 1‑year contract.

Required skills

• Root Cause Analysis (RCA)
• 5 Whys
• Fishbone/Ishikawa analysis
• FMECA
• Fault‑tree analysis
• CAPA development and effectiveness checks
• GMP compliance
• Master Batch Record (MBR) review

What we offer

• Competitive monthly salary SGD 5,000–7,000.
• Opportunity to work in a leading multinational biologics company.
• Exposure to cross‑functional teams and high‑impact projects.