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Engineer

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Amgen

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Location:
United States , Thousand Oaks

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Category:
-

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Contract Type:
Not provided

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Salary:

95914.00 - 116069.00 USD / Year
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Job Description:

As a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Analytical Engineering team you will support Clinical and Commercial Drug Substance plant operations. This role provides system owner oversight and lifecycle management of a wide range of devices in multiple production areas such as cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers. The successful candidate will work cross functionally to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.

Job Responsibility:

  • 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 spart 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

Requirements:

  • High school diploma / GED and 8 years of Engineering or Operations experience
  • Associate’s degree and 6 years of Engineering or Operations experience
  • Bachelor’s degree and 2 years of Engineering or Operations experience
  • Master’s degree
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
February 19, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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