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ERP Systems Analyst
Job in
Fishers, Hamilton County, Indiana, 46085, USA
Listed on 2026-10-09
Listing for:
INCOG BioPharma
Full Time
position Listed on 2026-10-09
Job specializations:
-
IT/Tech
IT Business Analyst, Systems Analyst, SAP Consultant
Job Description & How to Apply Below
We are looking for a Senior ERP Systems Analyst who will help with our growing IT department. Do you naturally create new ways to deliver exceptional results? We want to meet you!
Role Summary The ERP Systems Analyst – SAP Business ByDesign is a hands-on system support resource responsible for the day-to-day administration, configuration support, troubleshooting, and compliance maintenance of INCOG's SAP Business ByDesign ERP platform. Reporting to the Associate Director of Enterprise Systems, this role works closely with business stakeholders, the implementation partner, and cross-functional teams to ensure ByDesign remains stable, compliant, and aligned with INCOG's operational and GxP requirements.
This role is focused on sustaining and supporting the existing ByDesign environment — managing user needs, system configurations, integrations, and documentation in a regulated CDMO setting.
Essential Job FunctionsSAP Business ByDesign System Support & Administration Support and maintain SAP Business ByDesign configurations across functional areas including Financial Management (FI), Materials Management (MM), Procurement, Inventory, and Warehousing, ensuring system settings remain aligned with approved business requirements and INCOG's GxP-compliant baseline.
Perform day-to-day system administration tasks including user provisioning, role assignments, and access management in accordance with Segregation of Duties (SoD) principles and 21 CFR Part 11 access control requirements.
Troubleshoot and resolve system issues, configuration discrepancies, and user-reported defects in a timely manner, escalating to the implementation partner or SAP support when required.
Assist with the execution of system changes and enhancements, ensuring all modifications are processed through the appropriate change control workflow and documented in accordance with INCOG SOPs.Support master data maintenance activities for assigned functional areas, including data entry validation, periodic reviews, and coordination with business process owners to ensure ongoing data integrity.
Maintain and update configuration documentation, including work instructions, configuration records, and system change logs, ensuring records are current and inspection ready.
GxP Compliance & System Validation Support Support Computer System Assurance (CSA) activities for SAP Business ByDesign, assisting in the execution of risk assessments, test scripts, and validation documentation in alignment with GAMP 5 principles and INCOG's validation framework.
Assist in maintaining the ByDesign validated state by ensuring all changes and configuration updates are assessed for compliance impact prior to implementation and executed through a documented, audit-trail-compliant change control process.
Participate in periodic system reviews, user access reviews (UARs), and audit trail reviews, supporting ongoing compliance and flagging potential gaps to the Senior Manager of Enterprise Systems.
Apply working knowledge of FDA 21 CFR Part 11, GAMP 5, and applicable data integrity guidance as they relate to ERP systems in a GxP manufacturing environment.
Support preparation for FDA inspections and internal audits by ensuring that system documentation, configuration records, and change histories are complete, organized, and readily available.
Integrations & System Connectivity Support Support the ongoing operation and troubleshooting of integrations between SAP Business ByDesign and connected systems, including WMS and other operational platforms, coordinating with the implementation partner and relevant…
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