Job Description
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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 lay within them, youll 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 single use 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 ManagerProcessEngineering What Youwill Do Letsdo this!Letschange the world! In this vital role, you will oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems,optimizeprocesses, and ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations. The Senior ManagerProcessEngineering will join the Facilities & Engineering (F&E) groupreporting to the Facilities & Engineering (F&E)Director,partnering closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up, focusing onProcess engineering and plant equipmentas well as hiring and training the staff required to support startup and operations. Key Responsibilities Include Sitedesign,construction, start-up, and operational readiness: Execute and guide thecommissioning and qualification ofprocess equipmentin alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Ensure systems are installed,operatingsafely,andcomplywithpertinentenvironmental health/safetypractice,rulesand regulations. Perform engineering assessmentsforplant equipmentoperations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired. Site Operations Provide system ownershipforprocess equipmenttypically used in biologics manufacturing, includingUpstream(Seed train, production Bioreactors, Harvest), andDownstreamPurification(e.g.Chromatography and viral Filtration skids, UFDF), and CIP/SIPSkids. Lead a team ofProcessEngineeringprofessionals and serve as the main point of contact forProcessandequipment engineeringfunction. Establish clear expectations and prioritiestostaff. Encourage a culture of continuous improvement, partnership, and knowledge sharing.Providedevelopment opportunities, feedback, and actively listen to staff. Effectively collaborate with key customers and support groups (e.g.Manufacturing, Quality, Process Development, Maintenance, network partners). Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipment. Work with integrated service providers for day-to-day operational activities,breakdownand planned maintenance. Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements intoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment. Develop equipment maintenance programs, ensure the availability of spare parts, andcoordinatemaintenance activities to ensure systems are in proper working order. Ensure plant readiness and q