Manufacturing Business Applications Manager

Location: New York

** Nature and Scope
**** Essential Duties and Responsibilities
** Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
* 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.
** Education Requirements and Qualifications
** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements 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, 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.
* 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.
** Physical Environment and Requirements
*** Remote role with up to 25% travel to all locations within the organization.
** Expected Salary Range: ****$120,000-$140,000
** The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that…