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Senior Manager Manufacturing Systems Engineering - Automation

Amgen SA

Senior Manager Manufacturing Systems Engineering - Automation Join Amgen’s Mission of Serving Patients, and be part of a team that researches, manufactures, and delivers innovative medicines to help people live longer, fuller, happier lives. What You Will Do Lead a team of Automation Engineers and serve as the main point of contact for the automation function at ANC1 manufacturing, overseeing systems including Allen Bradley PLCs, Siemens D’ esigo CC, and Emerson DeltaV for process control. Define, drive, and deliver the automation and process control strategy within drug substance manufacturing. Serve as an experienced advisor to senior management, ensuring the automation development strategy aligns with Amgen Process Development strategy. Provide strategic and tactical leadership in day‑to‑day operational support, mentoring, staff development, and efficient use of resources. Develop support structures with internal and multi‑functional teams for capital projects, plant support, and network‑level initiatives. Contribute to department objectives and establish strategic direction within the Drug Substance Network for the F&E automation team. Maintain and improve automation system reliability in partnership with F&E, plant leadership, and other technical staff, focusing on maintenance excellence and failure prevention. Work with diverse groups (Manufacturing, Quality, PD, Automation, Technology, EHSS, Global Engineering) to drive business process improvements, translate needs into engineering solutions, and lead alternative analysis and proposal recommendations. Identify improvement opportunities, conduct analysis, recommend solutions, sponsor projects, and implement changes. Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Guarantee personnel safety during plant operations and engineering activities. Develop expense budget forecasts and adhere to department budgets, holding 100 % accountability for operational and capital expenses. Apply knowledge of compliance and regulatory aspects for operation, maintenance, equipment validation, and support inspections and audits. Maintain 100 % compliance with Amgen Enterprise cyber‑resiliency standards. Ensure processes and systems capture 100 % quality compliance for right‑first‑time delivery of automation solutions. Incorporate reporting functionality for all unit operations, including batch records, cleaning, sterilization systems, audit trail, and version control. Establish and manage service contracts with OEMs for system support, including service‑banked hours for specialized needs. Ensure all automation staff are trained and comply with GMP standards, managing internal and external training needs. Guarantee the automation staff are confident and capable of operating all automation systems, process equipment, and facility to provide 24 x 7 reliable support. Ensure the automation team actively participates in Work Center Team meetings, addressing day‑to‑day topics and resolving issues with multi‑functional teams. Support the automation team in delivering expense, department capital, construction, and GLAM‑DTI projects. Lead proactively to solicit staff feedback and maintain work‑life balance. What We Expect Of You Basic Qualifications High school diploma / GED and 12 years of Engineering and/or Project Management experience OR Associate’s degree and 10 years of Engineering and/or Project Management experience OR Bachelor’s degree and 8 years of Engineering and/or Project Management experience OR Master’s degree and 6 years of Engineering and/or Project Management experience OR Doctorate degree and 2 years of Engineering and/or Project Management experience In addition to meeting at least one of the above requirements, a minimum of 2 years of direct people‑management or leadership experience leading teams, projects, programs, or allocation of resources is required. Preferred Qualifications Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field. Experience with Emerson DeltaV DCS system, Siemens D’ esigo CC, Allen Bradley PLC, and advanced troubleshooting and system integration using OPC, Foundation Fieldbus, and Profibus. Direct knowledge of automation system design. Experience in programming, installation, and lifecycle management of automation and field‑instrumentation technologies. Experience with GMP biopharmaceutical automation equipment and systems such as buffer prep and hold, chromatography, single‑use mixing vessels, depth filtration, and solution prep. Experience integrating OEM automation software. Experience in programming, designing, installing, and managing manufacturing process controls and field‑instrumentation technologies. Knowledge of Fieldbus and Profibus technologies. Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in highly regulated environments (21 CFR Part11, ASTM2500, S88, S95). Self‑directed team player capable of cross‑functional collaboration. Strong leadership, technical writing, and communication skills. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen SA

Vacancy posted 2 days ago
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