Senior Manufacturing Systems Engineer: Automation

Senior Manufacturing Systems Engineer: Automation What you will do As a Senior Manufacturing Systems Engineer, you will 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. In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem‑solving techniques, project management, lifecycle management and Operational Excellence. 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. Ongoing operations 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications. 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. 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. 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 by applicable law. 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