Senior SAP ByDesign ERP Analyst — GxP & Compliance

INCOG BioPharma Services; Fishers (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Smoke-free campus

Equal opportunity employer

Job summary

INCOG BioPharma Services seeks a Senior ERP Systems Analyst to manage SAP ByDesign operations, configurations, and compliance in a GxP CDMO setting. You will work with stakeholders, partners, and cross-functional teams to keep ByDesign stable and audit-ready.

The role emphasizes system administration, integration support, and documentation, with a focus on FDA 21 CFR Part 11 adherence and change-control governance.

Qualifications

• 3–5 years hands-on SAP ByDesign or cloud ERP experience.
• Experience in GxP/regulatory environments (CSA/CSV) and 21 CFR Part 11.
• Strong documentation and change-control experience.
• Bachelor's degree in IT/CS/Life Sciences or related field.

Responsibilities

• Provide day-to-day SAP ByDesign support and administration across FI, MM, Procurement, Inventory, and Warehousing.
• Manage user provisioning, roles, and access following SoD and 21 CFR Part 11.
• Coordinate system changes through change control; ensure documentation is inspection-ready.
• Support CSA activities, validation, and audits; assist in FDA inspection prep.

Skills

SAP ByDesign

GxP compliance

CSV/CSA

Change control

Access control

Documentation

Data integrity

ERP administration

Jira ITSM

21 CFR Part 11

Education

B.S. in Information Technology/Computer Science/Life Sciences

Tools

Jira Service Manager

Job description

INCOG BioPharma Services seeks a Senior ERP Systems Analyst to manage SAP ByDesign operations, configurations, and compliance in a GxP CDMO setting. You will work with stakeholders, partners, and cross-functional teams to keep ByDesign stable and audit-ready.

The role emphasizes system administration, integration support, and documentation, with a focus on FDA 21 CFR Part 11 adherence and change-control governance.