Manager Manufacturing Single Use Systems - Holly ...

, 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.What you will doLetâs do this. Letâs change the world. In this vital role you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the- Manufacturing Support organization.ANC is a dynamic environment and an important supply facility for Amgenâs pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. In this vital role, you will act as the Manager for Single Use Systems and Cleaning Validation, leading a team responsible for the oversight, implementation, and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations, process development, engineering, supply chain, and quality.Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation.Lead development and execution of the siteâs Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies.Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development.Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility.Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions.Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections.Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant.Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies.Develop and implement training plans and programs to ensure staff are prepared and compliant.Maintain inspection readiness and support staff with audit or regulatory response strategy.,

Created: 2025-10-24