Manufacturing Business Applications Manager

American Regent, Inc.

4d•$120,000 - $140,000•Remote

About The Position

The Manufacturing Business Applications Manager will lead the strategy, design, deployment, governance, technical support, and continuous improvement of manufacturing business applications supporting pharmaceutical manufacturing operations across all American Regent, Inc. sites. This role owns a portfolio of digital manufacturing capabilities—including Manufacturing Execution Systems (MES) with electronic batch execution workflows and OEE/KPI performance reporting solutions—and serves as the primary link between Manufacturing, 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 integrated digital solutions. The ideal candidate will ensure manufacturing applications deliver value in shop floor execution, batch documentation, performance visibility, quality, traceability, and continuous improvement, while supporting regulatory compliance and operational excellence.

Requirements

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, data integrity (ALCOA+), and CSV/CSA expectations required.
Demonstrated expertise in pharmaceutical manufacturing processes, including batch execution, shop floor control, and material inventory traceability.
Hands-on experience driving digitalization initiatives, including replacement of paper-based processes with compliant electronic MES, Electronic Batch Records workflows, and manufacturing performance systems (OEE/KPI reporting) solutions.
Experience integrating manufacturing applications with SCADA, ERP, CMMS, LIMS, and supply chain systems.
Proven ability to partner effectively with Manufacturing, Quality, Engineering, IT, and OpEx teams.

Nice To Haves

Experience with leading MES platforms (e.g., Werum PAS-X, Siemens Opcenter, Emerson Syncade, or equivalent).
Experience supporting FDA inspections and audit readiness related to manufacturing systems.
Prior experience managing vendors, system integrators, and cross-site implementations.
Working knowledge of Lean Manufacturing and Operational Excellence (OpEx) principles and how digital systems enable continuous improvement.
Familiarity with Industry 4.0/Smart Manufacturing, advanced analytics, and digital strategy and manufacturing technologies.

Responsibilities

Technical ownership and lifecycle management of core manufacturing business applications, including MES 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 batch execution, replacing current paper-based records with compliant electronic workflows.
Enable real-time and historical OEE, KPI, and manufacturing performance reporting, ensuring data accuracy, consistency, and usability in support of Lean manufacturing and Operational Excellence (OpEx) initiatives.
Drive digitalization of pharmaceutical manufacturing processes, including shop floor workflows, data capture, deviation handling, production reporting, and continuous improvement activities.
Partner with Manufacturing, Quality, Engineering, Supply Chain, IT and OpEx/Lean teams to align digital solutions 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 from manufacturing digital solutions.
Manage vendors, system integrators, and internal support resources.
Perform any other tasks/duties as assigned by management.