Job Information
American Regent, Inc. Manufacturing Business Applications Manager in SHIRLEY, New York
Nature and ScopeThe Manufacturing Business Applications Manager will lead the strategy, design, deployment, governance,technical support, and continuous improvement of manufacturing business applications supportingpharmaceutical manufacturing operations across all American Regent, Inc. sites. This role owns a portfolio ofdigital manufacturing capabilities-including Manufacturing Execution Systems (MES) with electronic batchexecution workflows and OEE/KPI performance reporting solutions-and serves as the primary link betweenManufacturing, Quality, Engineering, IT, and Operational Excellence teams.The role is responsible for enabling compliant, data-driven, and increasingly digital manufacturing processes,moving the organization beyond current paper-based execution toward standardized, scalable, and integrateddigital solutions. The ideal candidate will ensure manufacturing applications deliver value in shop floor execution,batch documentation, performance visibility, quality, traceability, and continuous improvement, while supportingregulatory compliance and operational excellence. Essential Duties and ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to thisjob at any time. * Technical ownership and lifecycle management of core manufacturing business applications, includingMES platform with electronic batch execution workflows and OEE/KPI performance reporting solutions,within a regulated pharmaceutical manufacturing environment. * Lead and govern the selection, design, implementation, optimization, and sustainment of digital batchexecution, replacing current paper-based records with compliant electronic workflows. * Enable real-time and historical OEE, KPI, and manufacturing performance reporting, ensuring dataaccuracy, consistency, and usability in support of Lean manufacturing and Operational Excellence (OpEx)initiatives. * Drive digitalization of pharmaceutical manufacturing processes, including shop floor workflows, datacapture, deviation handling, production reporting, and continuous improvement activities. * Partner with Manufacturing, Quality, Engineering, Supply Chain, IT and OpEx/Lean teams to align digitalsolutions with operational, quality, and performance improvement objectives and IT architecture,cybersecurity, and data integrity standards. * Ensure systems are designed and maintained to comply with FDA regulations and GxP requirements,including 21 CFR Part 11, data integrity (ALCOA+), and CSV/CSA expectations. * Oversee integrations between manufacturing applications and enterprise systems such as SCADA, ERP,CMMS, LIMS, and supply chain platforms, enabling end-to-end data flow. * Develop and maintain a manufacturing applications roadmap aligned with digital manufacturing, Lean,and new Industry 4.0 initiatives. * Support change management, training, and user adoption to ensure sustained value realization frommanufacturing digital solutions. * Manage vendors, system integrators, and internal support resources. * Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Therequirements listed below are representative of the knowledge, skill and/or ability required. * Bachelor's degree in Engineering, Computer Science, Life Sciences, or other STEM related field required. * 10+ years of technical ownership of manufacturing business applications in a regulated pharmaceutical,biotechnology, or life sciences manufacturing environment required. * 10 + years of expertise in GxP regulations & requirements, including 21 CFR Part 11, Annex 11, dataintegrity (ALCOA+), and CSV/CSA expectations required. * Demonstrated expertise in pharmaceutical manufacturing processes, including batch execution, shopfloor control, and material inventory traceability. * Hands-