Senior Manufacturing Systems Engineer: Automation

Senior Manufacturing Systems Engineer: Automation – DeltaV As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a team of engineers responsible for building and maintaining automation systems and platforms that support GMP Drug Substance Plant Operations. We are building Amgen’s newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which will combine disposable technologies with traditional stainless‑steel equipment for maximum flexibility and sustainability. Key Responsibilities Provide automation technical leadership to a group of automation engineers building and maintaining automation systems and platforms that support GMP Drug Substance Plant Operations. Work hand in hand with the capital project team to deliver robust process automation systems for the new plant. Develop and maintain the process control system on the Emerson DeltaV distributed control system (DCS). Collaborate with process subject matter experts (SMEs) to transform key process requirements into digital automated solutions. Collaborate with business partners to improve workflow and productivity via automation. 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 in a GxP environment. Maintain Data Integrity Assessments with current Amgen and industry standards. Build business processes to support project scope in alignment with project timelines. Develop detailed specifications and engineering policies and procedures that affect multiple organizational units. Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO). Own and drive to completion Change Controls, CAPAs, and Deviations. Lead and support functional area projects to improve process equipment, utilities, and facilities, and large/sophisticated capital projects to integrate new drug substance manufacturing technologies. Lead and support technical root‑cause analysis, incident investigations, and troubleshooting of process control issues related to plant operations. Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing configuration changes, and supporting engineering and process qualification runs. Handle day‑to‑day operational support including 24×7 onsite/on‑call support, troubleshooting support to plant and manufacturing operations, process and utility automation systems, preventive and corrective maintenance, system administration, and automation system spare parts management. Prepare/review Standard Operating Procedures (SOP) and cGMP documents. Continuous curiosity to discover new and innovative ways to do business differently, better, and more cost effectively. Basic Qualifications High School Diploma / GED and 10years of Engineering experience Associate’s Degree and 8years of Engineering experience Bachelor’s Degree and 4years of Engineering experience Master’s Degree and 2years of Engineering experience Doctorate Degree (Preferred) Preferred Qualifications Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field. Direct knowledge of automation system design, process control engineering, and troubleshooting within GMP biopharmaceutical production facilities, including 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 integration of various OEM automation software. Extensive background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies. Experience with Emerson DeltaV DCS, Process Control Network design (including network segregation), virtual infrastructure design and implementation, and 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 21CFR Part11, ASTM2500, 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 that enhance safety, system reliability, and productivity in drug substance plant operations. Benefits You can expect competitive benefits and a collaborative culture that supports your professional and personal growth. Amgen offers a comprehensive Total Rewards Plan aligned with local industry standards. Salary Range 136,906.95USD – 185,227.05USD Equal Opportunity Employer Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected under applicable law. Amgen will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process and to perform essential job functions. #J-18808-Ljbffr Amgen Inc. (IR)