Amgen
Holly Springs, NC
Shift: Full time
Career Category Engineering Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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 Manager Manufacturing Systems Engineering - Automation What You Will Do Let’s do this. Let’s change the world. In this role The Senior Manager is responsible for providing technical and administrative leadership to a group of Automation Engineers accountable for administrating and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina ( ANC ). Responsibilities include meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation team applies the Corporate Automation Business Processes and drivers to deliver the automation services to the organization. As part of the Facilities Engineering (F E) group, the Senior Manager will work with the Director of Engineering at Amgen North Carolina . This role is expected to provide leadership as follows: Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC 1 manufacturing . Systems including Allen Bradley PLCs, Siemens D esi go CC for b uilding a utomation, and Emerson DeltaV for process control . Define, drive, and deliver the automation and process control strategy within Drug substance manufacturin g . Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy. Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources. Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives execution. Provid input into department objectives and establishing strategic direction within the Drug Substance Network for the F E automation team. Maintain and improve capabilities and automation systems reliability in partnership with F E and plant leadership, and other technical staff in the network, focusing on “ Maintenance Excellence ” systems failures and recurrence avoidance. Work with diverse groups (Manufacturing, Quality, PD, Automation, Technology , EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals. Identify areas of potential improvement, conduct analysis, recommend solutions, sponsor improvement projects, and implement. Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure the safety of all personnel during plant operations and engineering activities. Develop expense budget forecast and adhere to department budgets and spend for operational and capital expenses, holding 100% accountability. Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits. Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%. Ensure the right processes/systems are in place to capture 100% quality compliance for the right- first-time (RFT) delivery of automation solutions. Ensure that reporting functionality is incorporated for all unit operations for production Batch records, cleaning, and steriliza