Manufacturing Specialist Single Use Systems (SUS) - ...

, 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.Manufacturing Specialist ⓠSingle Use Systems (SUS) LeadWhat you will doLetâs do this. Letâs change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANCâs Manufacturing Support team, the Manufacturing Specialist will have ownership and oversight of Single Use Systems technology for the Manufacturing area, including generating training materials and / or providing training on scientific or technical aspects of the Single Use Systems. In addition, this role will have the opportunity to be involved on any of the following: Standard Operating Procedure (SOP) creation, review, and approval; develop, manage, and run change controls associated to area of expertise; and complete deviation investigations along with corresponding preventive/corrective action records. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to keep the manufacturing area operational.Provide technical support and subject matter expertise for Single Use Systems for the manufacturing area.Oversee and support ongoing development of all the manufacturing systems related to Single Use Systems including SOP, Training, Manufacturing Execution Systems/Batch Records, Quality Management System (e.g. Veeva/Trackwise) records, among others.Train staff (supervisors, operators, technical/QA/support) on Single Use systems.Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facilityFacilitate process, area, and equipment risk assessments as needed to identify risks, failure modes, and mitigating actionsEngage in regulatory inspections and in the NPI process to assess requirements for documentation, materials, training, and equipment modifications,

Created: 2025-10-04