Hiring: Validation SME – ASRS (Automated Storage & Retrieval Systems) / Warehouse Validation Company: CORE, a Unicon Company Location: Wilson, NC Job Posted Time: 2026-09-16 14:39:56 Target Skills & Keywords : Manufacturing Execution Systems About the job Experience: •10+ years of CQV experience in pharmaceutical, biotech, or medical device manufacturing environments Required Skills: •Author, execute, and review IQ, OQ, and PQ protocols for ASRS equipment, conveyance systems, robotics, and warehouse management/control systems (WMS/WCS) •Develop and execute qualification strategies for automated storage, retrieval, and material handling equipment supporting raw material and finished goods flow •Partner with engineering, automation, and quality teams during the design phase to build a CQV plan that ensures qualification is uneventful and audit-ready •Validate temperature, storage, and delivery conditions for materials moving through the ASRS, including scanning/verification systems used to confirm material integrity before use •Perform risk assessments, gap analyses, and impact assessments related to ASRS design and automation integration •Author and execute test protocols for point-to-point testing, alarm verification, and system interface qualification (WMS/WCS to ERP/MES) •Support FAT/SAT activities for ASRS equipment and vendor-supplied automation systems •Develop and maintain traceability matrices, URS, FS, and validation summary reports for the ASRS project Qualifications: •Bachelor's degree in Engineering or related technical discipline •Applied hands-on capability in ASRS, automated warehouse systems, or large-scale material handling/logistics equipment qualification •Strong background authoring and executing IQ/OQ/PQ protocols for automated/robotic systems •Solid functional working knowledge of cGMP, 21 CFR Part 11, and GAMP 5 •Strong technical writing skills for validation documentation (URS, FS, VSR, RTM) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!