Delta V Automation Engineer - Holly Springs, NC

, ATTENTION MILITARY AFFILIATED JOB SEEKERS, - 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 click the submit button and follow the next steps. Unless specifically stated otherwise, this role is 'On-Site' at the location detailed in the job post.Letâs do this. Letâs change the world. 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 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 readinessCollaborate 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 systemsSupport design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirementsSupport vendor FAT to ensure that control strategy and software code meet Amgen requirementsDevelop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processesCollaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategySupport commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)Support QA partners in performing computerized systems validation in a GxP environmentPerform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standardsSite OperationsOwn and drive to completion Change Controls, CAPAs, and DeviationsLead and support technical root cause analysis, incident investigations, and troubleshootingLead 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 facilityDrive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainabilitySupport day-to-day operations including rotational on-call supportPerform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards,

Created: 2025-11-01