Amgen - Holly Springs, NC
posted 3 months ago
At Amgen, we are on a mission to serve patients and are looking for an Automation Engineer to join our team at the new drug substance manufacturing plant in Holly Springs, North Carolina. This facility, known as the FleX batch facility, will integrate the latest disposable technologies with traditional stainless steel equipment, allowing for maximum operational flexibility. The facility will not only feature state-of-the-art drug substance manufacturing technologies but will also incorporate sustainability innovations aimed at reducing carbon emissions and waste, aligning with Amgen's goal of becoming a carbon-neutral company by 2027. In this vital role, you will collaborate closely with the capital project team to deliver robust automation systems essential for the operation of the new plant. Your responsibilities will include developing and maintaining process control automation solutions on the Emerson DeltaV Distributed Control System (DCS). You will work with process subject matter experts to understand key process requirements and translate them into effective digital automated solutions. Additionally, you will collaborate with business partners to identify how automation can enhance workflow and efficiency, ensuring that the solutions developed meet the needs of clients, customers, or end-users. You will also be responsible for providing clear documentation for the solutions and processes delivered, working closely with Quality Assurance partners to support computerized systems validation processes in a Good Manufacturing Practice (GxP) environment. Your role will involve maintaining Data Integrity Assessments in accordance with current Amgen and industry standards, as well as supporting commissioning and qualification efforts, including Automation Installation Verification/Automation Check Out (IV/ACO). As part of ongoing operations, you will lead and support functional area projects aimed at improving process equipment, utilities, and facilities, as well as integrating new drug substance manufacturing technologies into the facility. You will conduct technical root cause analysis, incident investigations, and troubleshooting on utilities and building control systems. Your leadership will extend to new product introductions and technology deployments, where you will perform automation engineering assessments and implement necessary system configuration changes. Day-to-day operational support will also be a key aspect of your role, including 24/7 onsite/on-call support, troubleshooting, preventative and corrective maintenance, and system administration.