Principal Validation Engineer, Bio/API & Tech Transfer

Amgen; Singapore; On-site; SGD 200,000 - 280,000; Full time

Job summary

Amgen Singapore is seeking a Principal Validation Engineer to lead validation strategies for synthetic DS/API and biologic DP across CMOs and support tech transfer activities. The role focuses on compliant process validation and cleaning validation, with experience in FDP qualification as a plus.

Occasional JAPAC travel is required. The candidate will drive risk-based decisions, develop playbooks for audits, and oversee validation documentation in collaboration with global quality teams and

Qualifications

• Direct experience with validation of processes in synthetic drug substance manufacturing or aseptic DP filling.
• Experience with qualification/validation of packaging processes is a plus.
• Experience with tech transfer / NPI and process validation is required or desired.

Responsibilities

• Be an integral quality member of cross-functional contract manufacturing teams.
• Translate Amgen requirements into the CMO language.
• Identify and assess validation/quality risks to enable risk-based decisions.
• Validation document author/approver.
• Oversight of synthetic API manufacturing process validation and cleaning validation.
• Oversight of aseptic DP filling process validation and cleaning validation.
• Oversight of packaging process qualification, device and combination product qualifications.
• Determine sampling plans and acceptance criteria for packaging processes.
• Implement statistical methods to create risk-based sampling plans.
• Prepare materials for audits/inspections.
• Perform validation change control assessments.
• Review/approve validation deviations.

Skills

Validation engineering

Tech transfer

Quality systems

Process validation

Statistical sampling

Job description

Amgen Singapore is seeking a Principal Validation Engineer to lead validation strategies for synthetic DS/API and biologic DP across CMOs and support tech transfer activities. The role focuses on compliant process validation and cleaning validation, with experience in FDP qualification as a plus.

Occasional JAPAC travel is required. The candidate will drive risk-based decisions, develop playbooks for audits, and oversee validation documentation in collaboration with global quality teams and