Engineer I – Process Engineering (Biologics)

Career Category Engineering Job Description Join Amgen's Mission to Serve Patients At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact. Engineer I – Process Engineering (Biologics Process Equipment) What you will do Reporting to the Senior Engineer/ Team Lead/ Manager, this Process Engineer position is primarily responsible for providing operation and New Product Introduction (NPI) support for ASM1 Process Equipment. This role will serve as a system owner for an assigned portfolio of process-support equipment in ASM for the Process Engineering team in the Facilities & Engineering department, which collaborates with Engineering Support and Maintenance team, to deliver uninterrupted plant operations. This function operates in conjunction with the manufacturing team to ensure the appropriate and timely completion of cGMP maintenance activities with minimum disruption to manufacturing. The scope covers both upstream and downstream process areas, including cell culture and harvest filtration, as well as viral inactivation, purification and drug substance bulk fill. This role will assume the system owner role, taking ownership of various process equipment that are used for manufacturing process or supporting manufacturing process. It will be the technical resource or equipment subject matter expert (SME) for assigned systems to ensure that the equipment operates, function and performs as intended and is maintained in a validated state. Scope of work includes managing, planning and implementation of changes, driving deviation investigations, resolving equipment related process interruptions and development of equipment maintenance program. This role requires highly cross functional interactions with key site functions to ensure success in production and release performance. Individual must be able to effectively communicate and collaborate closely with the team members and various SME to ensure equipment are operational to sustain daily operations, resolve operation challenges and implement effective measures to address the challenges to ensure without compromising on safety and compliance. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide engineering network. In addition, it will also provide advance technical support to ensure the readiness of the equipment/ facility for successful introduction of new products in ASM. The role will be a liaison between corporate engineering and site operations in the design and implementation of new equipment and/or equipment modifications. Main Responsibilities : Daily Operations Own the day-to-day engineering support, equipment performance, validated state, maintenance plans and lifecycle actions for an assigned portfolio of ASM1 Process Equipment. Present equipment qualification and equipment related investigations and quality management system records in all site regulatory inspections Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operations activities. Lead equipment investigations of moderate complexity, identify root causes, assess technical options, recommend corrective and preventive actions, and drive approved actions to closure. Effectively communicate to the customers on the subsequent plans, short term, and long-term mitigating actions. Collaborate closely with cross functional SME to implement effective corrective, preventive action and improvements to eliminate or mitigate future recurrence. Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost. Perform periodic review and maintain process equipment in validated state. Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state. Accountable for deviation/change control associated to process equipment performance. Act as technical owner for assigned deviations and change controls, ensuring accurate technical assessment, timely execution and closure. Final approval remains with designated Engineering and Quality approvers. Own defined equipment-readiness deliverables for NPI and site projects, including qualification support, punch-list closure, maintenance and spare-parts readiness, and system turnover Provide technical guidance to Manufacturing, Maintenance, Quality and project teams for assigned equipment and coordinate implementation of agreed technical solutions. Continuous improvements, Innovation and operational sustainability Participate in related AMGEN network forums to determine innovative opportunities to improve reliability, efficiency, agility and differentiation. Continuously improve business intelligence capabilities utilizing big data analysis tools to extract, analyze and trend performance data for predictive monitoring and troubleshooting. Actively seek opportunities for continuous improvement to improve efficiencies and differentiation through flexible use of advance technologies and best industry practices. Benchmark equipment performance (e.g., reliability, productivity) and determine improvement plans. Build system and capabilities to drive improvements to equipment reliability and maintenance optimization Periodically review and/or improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability. Design & Project Engineering: Support the functional lead in providing ASM1 Process Equipment readiness support for NPI, GLAM and Site Projects for Process-Support Equipment Where appropriate, provide engineering advice to commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment. Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team. Develop technical solutions to technical problems of moderate complexity requiring analysis and engineering judgment. Organization Leadership Work in teams by educating customers on lesson learns, collaborate with customers managers to identify knowledge or trainings gaps. Deliver strong result in the right way by consciously being a role model that ensure results are deliver without compromising on core AMGEN values. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities. What we expect of you Bas