Amgen · 1 month ago
Senior Manufacturing Systems Engineer: Automation - DeltaV
US - North Carolina - Holly Springs
Full-time
Onsite
Mid, Senior Level
$143K/yr - $163K/yr
4+ years expAmgen is a biotechnology company dedicated to serving patients living with serious illnesses. The Senior Manufacturing Systems Engineer will provide automation technical leadership to a team, ensuring the development and maintenance of automation systems that support GMP Drug Substance Plant Operations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
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 focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
Support day-to-day operations including rotational on-call support
Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Qualification
Required
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
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
Benefits
Competitive and comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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