Engineer

Role Summary

Join Amgen’s mission to serve patients living with serious illnesses. Since 1980, Amgen has helped pioneer biotech and deliver medicines across Oncology, Inflammation, General Medicine, and Rare Disease. We reach millions of patients each year and strive to improve lives through research, manufacturing, and the delivery of innovative medicines. Our culture is collaborative, innovative, and science-based.

Responsibilities

• Serve as team lead working with individuals and teams in Analytical, Engineering, Instrumentation, and Manufacturing to support plant operations.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on a diverse portfolio of analytical systems.
• Perform job plan and preventative maintenance schedule optimization to reduce labor hours required to maintain instruments.
• Own change control records, CAPA records and deviations as it relates to analytical systems.
• Coordinate offsite vendor support and maintenance of equipment service contracts.
• Lead and support new technology introduction and lifecycle replacements of aging equipment by ensuing qualification requirements are met.
• Provide Continuous Improvement initiatives to mitigate potential failures and reduce production delay hours.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Support staff proficiency by training team members and standardizing best practices.
• Collaborate with Amgen Drug Substance Plant network to enhance knowledge base and identify improvements for implementation at ATO.
• Draft and revise standard operating procedures, forms, and reports.
• Manage spare parts inventory and strategy for level 1, GMP equipment.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Day-to-day Operational Support including:
  • Direct Manufacturing Support required for Critical Operations
  • 24 x 7 Onsite/On Call as required
  • Trouble shooting Support for analytical instruments in multiple DS plants
  • Analytical Equipment Administration
  • Daily manufacturing and engineering work center team meetings
  • Preventative and corrective maintenance
  • Spare parts management

Qualifications

• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associate’s degree and 6 years of Engineering or Operations experience OR
• Bachelor’s degree and 2 years of Engineering or Operations experience OR
• Master’s degree

Education

• High school diploma / GED
• Associate’s degree
• Bachelor’s degree
• Master’s degree