Amgen · 7 hours ago
Senior Manufacturing Systems Engineer: Automation
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a biotechnology company dedicated to serving patients living with serious illnesses. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to build and maintain various automation systems for the GMP Drug Substance Plant Operations, working closely with project teams to deliver robust solutions.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS)
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Collaborate with business partners to understand how automation can improve workflow and productivity. 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
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
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment
Own and drive to completion Change Controls, CAPAs, and Deviations
Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility
Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable
Handle Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, Preventive and Corrective Maintenance, System Administration, and Automation System spare parts management
Prepare/review Standard Operating Procedures (SOP) and cGMP documents
Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively
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 process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform sophisticated troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is preferred
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
Strong leadership, technical writing, and communication/presentation skills
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
Recent News
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2026-02-06
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