Business System Analyst with Delivery, Devices, & Connected Solutions (DDCS)

Job Title: Business System Analyst with Delivery, Devices, & Connected Solutions (DDCS)

Key Skills: Stakeholder Management, Data Flow Mapping, Gap Analysis, Data Governance, Data Integrity (ALCOA+), GxP, Medical Device.

Experience: 8-10 Years’ experience

Location: Indiana Polis, Indiana

We at Coforge are hiring experienced professionals with strong Business Analysis, Requirements Gathering, Data Flow Analysis, Stakeholder Management, GxP Compliance, Medical Device Development, V&V, DHF, FMEA, LIMS, ELN, and Data Governance experience.

Key Responsibilities:

• Gather and document business and data requirements from stakeholders.
• Conduct process mapping, workflow analysis, and gap analysis.
• Create data flow diagrams, data domain models, and requirements documentation.
• Collaborate with business SMEs, data architects, and engineering teams.
• Analyze data movement across systems and identify process improvements.
• Support data governance, compliance, and regulatory requirements (GxP, DHF, V&V).
• Evaluate ELN, LIMS, PLM, and related laboratory systems.
• Facilitate stakeholder meetings and manage requirement traceability.
• Provide documentation for data transformation and integration initiatives.
• Support Agile delivery, sprint planning, and backlog refinement.
• Drive alignment between business, technical, and data teams.
• Present findings, recommendations, and project artifacts to leadership.

Required Skills & Experience

• 5+ years of Business Analysis, Systems Analysis, or Data Analysis experience.
• Strong expertise in Requirements Gathering, Process Mapping, and Gap Analysis.
• Experience creating Data Flow Diagrams, Data Dictionaries, and RTMs.
• Strong stakeholder management and workshop facilitation skills.
• Experience in Pharma, Biotechnology, Medical Device, or Life Sciences domains.
• Knowledge of GxP, ALCOA+, V&V, DHF, FMEA, CTD, and BLA processes.
• Experience with LIMS, ELN, PLM, and Document Management Systems.
• Understanding of Data Governance, Data Architecture, and Data Migration.
• Familiarity with Bronze, Silver, and Gold Data Layers.
• Experience with Agile/Scrum methodologies and backlog management.
• Excellent documentation, communication, and analytical skills.
• Preferred: Benchling, Signals, LabVantage, Veeva, Jama, Teamcenter, Oracle Agile PLM, and CBAP/PMI-PBA certifications.