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Manufacturing Execution Systems Specialist

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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:
Employment contract

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Salary:

107545.40 - 145502.60 USD / Year

Job Description:

This role is focused on design, development, validation, and continuous improvement of Electronic Batch Records (EBRs) and MES capabilities to enable reliable, compliant, and efficient manufacturing processes. You will act as a technical MES leader, partnering cross-functionally with Manufacturing, Process Development, Supply Chain, Quality, and Engineering to ensure MES solutions align with business processes and regulatory requirements.

Job Responsibility:

  • Design, develop, and maintain DP Manufacturing Electronic Batch Records (EBRs) using Körber PAS-X
  • Translate DP manufacturing processes / user requirement specifications into compliant MES templates, recipes, and workflows
  • Ensure EBRs and data reporting out of MES are robust, efficient, and aligned with GMP requirements
  • Support validation activities for MES / EBRs including testing and defect resolution
  • Provide day-to-day MES support to manufacturing operations, including troubleshooting and on-call support
  • Partner with NPI leads to enable MES readiness for New Product Introductions
  • Support deployment of new MES capabilities and system integrations (SAP, PI, DeltaV, Rockwell, Kepware)
  • Identify and implement improvements to MES design, usability, and performance
  • Contribute to MES standardization and best practices across the site and network
  • Support change control activities ensuring compliance with GMP procedures
  • Collaborate cross-functionally and communicate MES-related updates effectively

Requirements:

Doctorate degree OR Master's degree and 2 years of Manufacturing Execution Systems experience OR Bachelor's degree and 4 years of Manufacturing Execution Systems experience OR Associate's degree and 8 years of Manufacturing Execution Systems experience OR High school diploma / GED and 10 years of Manufacturing Execution Systems experience

Nice to have:

  • Hands-on experience with Körber PAS-X (EBR design and development)
  • Experience with MES validation and lifecycle management in a GMP environment
  • Strong technical writing and communication skills
  • Strong familiarity with Drug Product manufacturing processes (formulation, filling, inspection, packaging)
  • Experience with system integrations (SAP, PI, DeltaV, Rockwell, Kepware)
  • Familiarity with quality systems (change control, deviations, CAPA, validation)
  • Strong troubleshooting and analytical problem-solving skills
  • Experience supporting NPIs from an MES perspective
  • Ability to translate manufacturing processes / user requirements specifications into MES solutions
  • Ability to manage multiple priorities in a fast-paced environment
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:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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