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Senior Manufacturing Systems Engineer

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Amgen

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Location:
United States , Holly Springs

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

147421.00 - 177467.00 USD / Year
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Job Description:

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The facility will feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, and integrate sustainability innovations.

Job Responsibility:

  • Provide automation technical leadership to a group of automation engineers
  • Work with the capital project team to deliver robust process automation systems
  • Support site design, construction, start-up, and operational readiness
  • Collaborate with key stakeholders and end-users to understand key process requirements and develop solutions
  • Support design phases to ensure design aligns with specifications
  • Support vendor FAT to ensure control strategy and software code meet requirements
  • Develop and maintain engineering and maintenance documentation
  • Collaborate to develop commissioning and qualification plans
  • Support commissioning and qualification including Automation Installation Verification/Automation Check Out
  • Support QA partners in performing computerized systems validation
  • Perform Data Integrity Assessments
  • Own and drive to completion Change Controls, CAPAs, and Deviations
  • Lead and support technical root cause analysis, incident investigations, and troubleshooting
  • Lead and support functional area projects and capital projects
  • Drive continuous improvement for process automation systems
  • Support day-to-day operations including rotational on-call support
  • Perform and maintain Data Integrity Assessments

Requirements:

  • High School diploma/GED and 10 years of engineering experience
  • Associate’s degree and 8 years of engineering experience
  • Bachelor’s degree and 4 years of engineering experience
  • Master’s degree and 2 years of engineering experience
  • Doctorate degree
  • Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
  • Direct knowledge of automation system design
  • Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
  • Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
  • Experience in integrating various OEM automation software
  • Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies
  • Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
  • Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
  • Self-directed team player able to work cross-functionally
  • Strong leadership, technical writing, and communication skills
  • Ability for domestic and international travel
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
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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