Manufacturing Informatics Lead, Pharma Operations

Sun Pharmaceutical Industries, Inc.; Indiana; Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Sun Pharmaceutical Industries Ltd. seeks a Manufacturing Informatics Lead to oversee MES, OT, and digital manufacturing systems.

You will ensure availability, validation, security, and lifecycle management of manufacturing applications and IT/OT infrastructure in a GxP-regulated setting. Responsibilities include driving digitalization initiatives, system integrations, data integrity controls, and regulatory compliance.

Qualifikationen

• Bachelor’s degree or higher in a related engineering discipline.
• 5–8 years in IT operations within pharma manufacturing preferred.
• Experience with regulatory compliance and CSV.
• Strong knowledge of IT/OT concepts and manufacturing systems.

Aufgaben

• Lead and support Manufacturing Informatics, MES, OT, and digital manufacturing systems operations.
• Ensure availability, validation, security, and lifecycle management of manufacturing apps and IT/OT infrastructure.
• Drive digitalization, system integrations, and continuous improvement in a GxP environment.
• Maintain data integrity, regulatory compliance, and audit readiness.

Kenntnisse

SCADA

PLC

CSV

GAMP 5

Data Integrity

OT Security

CSV validation

21 CFR Part 11

EU Annex 11

Pharma Manufacturing Systems

Regulatory Compliance

Ausbildung

Bachelor’s degree in Computer Science, Electronics, Instrumentation, Automation Engineering

Tools

MES systems

Jobbeschreibung

Sun Pharmaceutical Industries Ltd. seeks a Manufacturing Informatics Lead to oversee MES, OT, and digital manufacturing systems.

You will ensure availability, validation, security, and lifecycle management of manufacturing applications and IT/OT infrastructure in a GxP-regulated setting. Responsibilities include driving digitalization initiatives, system integrations, data integrity controls, and regulatory compliance.