Senior Automation Engineer - Drug Substance Manufacturing

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon‑neutral company by 2027. Senior Manufacturing Systems Engineer: Automation What You Will Do Let’s do this. Let’s change the world. 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 DrugSubstancePlant Operations. The schedule for this position will be: 4 days x 10 hour shift: Wednesday through Saturday. 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 a solid understanding of various automation platforms, integration between different platforms, analytical problem‑solving techniques, project management, lifecycle management and Operational Excellence. 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. On‑going 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. Manage day‑to‑day operational support including 24x7 onsite/on‑call operational 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. 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 advanced 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). 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 our teammates’ professional and personal growth and well‑being. Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans and bi‑annual company‑wide shutdowns. Flexible work models, including remote work arrangements, where possible. #J-18808-Ljbffr Amgen