Integration Consultant supporting integrations between MasterControl and SAP in a regulated pharmaceutical environment. Collaborating with IT and stakeholders to ensure compliance with industry regulations.
Responsibilities
Analyze and define data flow between MasterControl and SAP
Collaborate with internal IT, QA, and Regulatory stakeholders
Support the integration using middleware or custom APIs
Ensure compliance with 21 CFR Part 11, GAMP5, and data integrity protocols
Lead or support CSV documentation (URS, RTM, IQ/OQ/PQ)
Troubleshoot validation, security, and data reconciliation issues
Requirements
Hands-on experience with SAP (S/4HANA or ECC) and supplier master data
Direct work with MasterControl or similar eQMS platforms
Integration experience in cloud-to-on-prem environments
Experience in middleware tools (SAP PI/PO, MuleSoft, Boomi, APIs)
Deep knowledge of GxP, CSV, and 21 CFR Part 11
Experience with system architecture, validation planning, or integration testing
Familiarity with audit prep and supporting FDA or client audits
Background in life sciences/pharma/biotech
Must have current US work authorization
Benefits
Equal employment opportunities (EEO) to all employees
Complies with applicable state and local laws governing nondiscrimination in employment
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