Engineer System Owner - Packaging

About the role

Amgen is seeking an Engineer System Owner for Packaging to apply engineering expertise in optimizing complex manufacturing systems. The role focuses on driving operational excellence, ensuring compliance, and supporting continuous improvement across packaging operations.

Key responsibilities

• Support or lead deviations, CAPAs, technical assessments, change controls, periodic reviews, and internal/external audits.
• Lead corrective and preventive actions, including effectiveness verification.
• Develop maintenance strategies and monitor equipment reliability using key performance indicators.
• Conduct root cause analysis, document findings, and develop equipment testing protocols.
• Review, update, and create validation protocols, design documents, SOPs, and data‑integrity assessments.
• Collaborate with QA, Validation, Facilities, and other cross‑functional teams to ensure document quality and compliance.
• Manage equipment lifecycle and maintenance work orders in Maximo.
• Partner with project managers and external consultants to define system modifications and meet project scope, schedule, and quality goals.

Required profile

Required skills

• Maximo

What we offer

• Opportunity to impact patients worldwide through innovative biotech manufacturing.
• Collaborative, science‑driven culture with focus on continuous learning.