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Senior Manufacturing Systems Engineer

United States, Holly Springs 147421.00 - 177467.00 USD / Year · Job Posted February 14, 2026
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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

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Senior Manufacturing Systems Engineer

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...
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United States , Holly Springs
Salary
Salary:
147421.00 - 177467.00 USD / Year
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Expiration Date
Until further notice
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Requirements
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
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  • Direct knowledge of BAS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software
  • Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation technologies
  • Experience with Siemens Building Automation system, Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities with Amgen DTI, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet 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
Job Responsibility
Job Responsibility
  • Provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations
  • Work hand in hand with the capital project team to deliver robust automation systems to operate the new plant
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  • Synthesize requirements from clients, customers or end-users to develop the best automation solutions
  • Provide clear documentation for delivered solutions and processes
  • work closely with QA partners while supporting computerized systems validation processes in a GxP environment
  • Maintain Data Integrity Assessments with the current Amgen and Industry standards
  • Maintain detailed specification and engineering policies and procedures that affect multiple organizational units
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What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
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Senior Manufacturing Systems Engineer: Automation

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Salary:
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  • Basic Qualifications: High School Diploma / GED and 10 years of Engineering experience OR Associate's Degree and 8 years of Engineering experience OR Bachelor's Degree and 4 years of Engineering experience OR Master's Degree and 2 years of Engineering experience OR Doctorate Degree
  • Preferred Qualifications: Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
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  • 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
  • Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution
  • Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations
  • Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations
  • The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making
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  • Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
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  • work closely with QA partners while supporting computerized systems validation processes in a GxP environment
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  • Build the business processes to support the project scope in alignment with project timelines
  • Develop detailed specification and engineering policies and procedures that affect multiple organizational units
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Salary:
147421.00 - 177467.00 USD / Year
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Expiration Date
Until further notice
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  • High School Diploma / GED and 10 years of Engineering experience
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  • Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies
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  • 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
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  • Synthesize requirements from clients, customers or end-users to develop the best automation solutions
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  • work closely with QA partners while supporting computerized systems validation processes in a GxP environment
  • Maintain Data Integrity Assessments with the current Amgen and Industry standards
  • Build the business processes to support the project scope in alignment with project timelines
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  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
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