Senior Validation Engineer — GMP Compliance & Strategy

AMGEN SINGAPORE MANUFACTURING PTE. LTD.; Singapore; On-site; SGD 100,000 - 170,000; Full time

Job summary

Amgen Singapore Manufacturing PTE. LTD. seeks a Senior Validation Engineer I to lead the validation team and provide technical support across commissioning, qualification, cleaning validation, and lifecycle maintenance.

The role requires collaboration with Manufacturing, Engineering, Quality, and Supply Chain to meet regulatory expectations. You will own validation strategies, SOPs, deviations, CAPAs, and change controls while mentoring junior engineers and driving continuous improvement in a

Qualifications

• Proven ability to communicate and collaborate with technical and management staff.
• Extensive experience in equipment qualification & cleaning validation.
• Experience in validation protocols, reports, and change management.
• Experience with cleaning validation and controlled temperature chambers.

Responsibilities

• Lead validation engineers and provide technical support for commissioning, qualification, cleaning validation and lifecycle maintenance.
• Establish validation strategies aligned with Amgen standards and regulatory expectations.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain and Process Development.
• Provide SME support and represent validation for filings, audits and inspections.
• Own SOPs, deviations, CAPAs, validation schedules and change controls.
• Mentor cross-functional team members and drive continuous improvement initiatives.
• Drive operational excellence within validation workspace.

Skills

Written and verbal communication

Self-directed work

Time management

Multi-tasking

Education

Doctorate Degree

Master’s degree in engineering

Bachelor’s degree in engineering

Diploma in Engineering

Job description

Amgen Singapore Manufacturing PTE. LTD. seeks a Senior Validation Engineer I to lead the validation team and provide technical support across commissioning, qualification, cleaning validation, and lifecycle maintenance.

The role requires collaboration with Manufacturing, Engineering, Quality, and Supply Chain to meet regulatory expectations. You will own validation strategies, SOPs, deviations, CAPAs, and change controls while mentoring junior engineers and driving continuous improvement in a