Senior Validation Engineer – API & Biologic DP

Biopharma Careers; Singapore; On-site; SGD 150,000 - 210,000; Full time

Job summary

Amgen Singapore seeks a Principal Validation Engineer to lead validation strategies for synthetic DS/API and aseptic DP, coordinating with global quality teams and contract manufacturers. You will drive qualification programs, risk-based decisions, and change control across JAPAC sites.

The role requires extensive experience in validation, tech transfer, and regulatory readiness, with travel to CMOs in the region.

Qualifications

• Doctorate/Master's/Bachelor's with extensive validation experience
• Experience validating synthetic API and aseptic DP processes
• Knowledge of OQ/PQ/PPQ and validation documentation standards

Responsibilities

• Be integral quality member of cross-functional contract manufacturing teams
• Translate requirements into CMO language and assess risks
• Author/approve validation documents and deviations
• Oversee validation of API, DP, packaging and device/combination products
• Support tech transfer/NPI and change control activities
• Prepare materials for audits/inspections and regulatory responses
• Drive Operational Excellence and continuous improvement

Skills

Validation

Tech transfer

Statistical methods

Regulatory knowledge

cGMP

Quality systems

Education

Doctorate degree + 2 years related experience

Master's degree + 6 years related experience

Bachelor's degree + 8 years related experience

Job description

Amgen Singapore seeks a Principal Validation Engineer to lead validation strategies for synthetic DS/API and aseptic DP, coordinating with global quality teams and contract manufacturers. You will drive qualification programs, risk-based decisions, and change control across JAPAC sites.

The role requires extensive experience in validation, tech transfer, and regulatory readiness, with travel to CMOs in the region.