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 lay 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 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 Manager P rocess Engineering What you will do Let’s do this! Let’s change 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, optimize processes, and ensure the company s engineering efforts align with strategic objectives . You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations. The Senior Manager Process Engineering will join the Facilities Engineering (F E) group reporting 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 domain expertise to support operations upon start-up, focusing on Process engineering and plant equipment as well as hiring and training the staff required to support startup and operations. Key responsibilities include : Site design, construction, start-up, and operational readiness: Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements , while working in partnership with global engineering during site installation . E nsure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Ensure systems are installed , operating safe l y , and comply with pertinent environmental health/safety practice , rules and regulations. P erform engineering assessments for plant equipment operations , implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required . Site O perations: Provide system ownership for process equipment typically used in biologics manufacturing, including Upstream (S eed train , p roduction Bioreactors, Harvest ) , and D ownstream P urification ( e.g. Chromatography and viral Filtration skids, UFDF ) , and CIP/SIP Skids . Lead a team of Process Engineer ing professionals and serve as the main point of contact for Process and equipment engineering function . Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development 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 of process equipment . Work with integrated service providers for day-to-day operational activities, breakdown and planned maintenance. Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order. Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process