Delta V Automation Engineer - Holly Springs, NC

Delta V Automation Engineer - Holly Springs, NC

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

As a Manufacturing Systems Engineer, you will work with a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant. Site design, construction, start-up, and operational readiness Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements Support vendor FAT to ensure that control strategy and software code meet Amgen requirements Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO) Support QA partners in performing computerized systems validation in a GxP environment Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards Site Operations Own and drive to completion Change Controls, CAPAs, and Deviations Lead and support technical root cause analysis, incident investigations, and troubleshooting Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability Support day-to-day operations including rotational on-call support Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards