Senior Validation Engineer, GMP & Regulatory Lead

Amgen SA; Singapore; On-site; SGD 90,000 - 135,000; Full time

Job summary

Amgen is seeking a Senior Validation Engineer I in Singapore to lead validation activities across commissioning, qualification and cleaning validation, ensuring regulatory readiness and robust lifecycle maintenance. The role requires collaboration with Manufacturing, Quality, and Process Development to align with global Amgen standards.

You will mentor teams, drive continuous improvement, and support filings and inspections while upholding GMP requirements and rigorous documentation practices.

Qualifications

• Demonstrated expertise in validation and cleaning validation.
• Experience with regulatory submissions and audits is preferred.
• Strong written and verbal communication for technical writing and presentations.
• Ability to lead cross-functional teams and manage timelines.

Responsibilities

• Provide technical support and lead validation engineers for commissioning, qualification, cleaning validation and lifecycle maintenance.
• Establish validation strategies and procedures aligned with regulatory expectations.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain and Process Development.
• Provide SME support and represent validation for filings, audits and inspections.
• Mentor and coach cross functional team members on validation knowledge.
• Drive Operational Excellence initiatives within the validation space.

Skills

Validation expertise

Quality systems

Regulatory experience

Documentation proficiency

Cross-functional collaboration

Education

Doctorate in Engineering

Master’s in Engineering

Bachelor’s in Engineering

Diploma in Engineering

Tools

GMP systems

QA software

Equipment qualification

Job description

Amgen is seeking a Senior Validation Engineer I in Singapore to lead validation activities across commissioning, qualification and cleaning validation, ensuring regulatory readiness and robust lifecycle maintenance. The role requires collaboration with Manufacturing, Quality, and Process Development to align with global Amgen standards.

You will mentor teams, drive continuous improvement, and support filings and inspections while upholding GMP requirements and rigorous documentation practices.