Senior Validation Engineer

About the role

Amgen is hiring a Senior Validation Engineer for its Singapore manufacturing site in Tuas. The role provides technical support and leads a team of validation engineers covering commissioning, qualification, cleaning validation and validation lifecycle maintenance, and works closely with Manufacturing, Engineering, Quality, Supply Chain and Process Development.

Key responsibilities

• Establish validation strategies and procedures aligned with Amgen operating standards and regulatory expectations.
• Coordinate with internal teams to meet validation requirements and act as subject matter expert for SOPs, deviations, CAPA, validation schedules and change controls.
• Support filings, audits and regulatory inspections, and escalate major validation issues to operations management.
• Maintain the site validation master plan and monitor equipment and system validation status and regulatory compliance.
• Deliver cleaning validation outputs, including cleaning strategies, characterization reports and acceptance limits, and execute validation protocols and reports.
• Oversee validation tasks for manufacturing equipment, supply chain facilities and analytical laboratories, and advise clients on equipment validation.
• Execute validation tasks for Controlled Temperature Chambers (CTC), including COTS units, and work with project leads on commissioning and qualification milestones.
• Drive operational excellence, mentor and coach team members, and support continuous improvement.

Required profile

• Doctorate, or Master's in engineering with 2 years of experience in a pharmaceutical company or GMP environment, or Bachelor's in engineering with 4 years of such experience, or Diploma in Engineering with 8 years of experience.
• Demonstrated written and verbal communication, including technical writing and presentations.
• Ability to work independently in a fast-paced environment, with good time management and attention to detail.
• Selection is subject to meeting the medical requirements of the job scope.

Required skills

• Equipment qualification and cleaning validation, including validation strategies and procedures.
• Reviewing and approving validation protocols and reports for commissioning, qualification and change management.
• Technical execution of cleaning validation, steaming validation (autoclaves) and CTC validation.
• Maintaining the validated state through continued verification and resolving complex validation investigations using root cause analysis.
• Supporting regulatory submissions, inspection responses and explaining validation matters to auditors.
• Training and coaching of junior engineers and managing validation resources.