Sr. Executive- Mfg. Informatics

Sun Pharmaceutical Industries, Inc.; Indiana; On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

SCADA

PLC

CSV

GAMP 5

Data Integrity

OT Security

CSV validation

21 CFR Part 11

EU Annex 11

Pharma Manufacturing Systems

Regulatory Compliance

Education

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

Tools

MES systems

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Summary/ Areas Of Responsibility

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Summary:

The Job holder will be responsible to Lead and support Manufacturing Informatics, MES, OT, and digital manufacturing systems operations. Responsible for ensuring the availability, compliance, validation, security, and lifecycle management of manufacturing applications, automation systems, and equipment-integrated IT/OT infrastructure. Support and drive digitalization initiatives, system integrations, and continuous improvement programs while maintaining regulatory compliance, data integrity, and operational excellence in a GxP-regulated environment.

Areas Of Responsibility:

• Administer and support Manufacturing Systems including PLC, HMI, SCADA, IPC, Balances, and IPQA instruments.
• Manage and maintain Manufacturing Informatics platforms and L2 integration (IT/OT Integration) supporting shop-floor operations and real-time production monitoring.
• Support global manufacturing digitalization, including electronic batch records (EBR), paperless operations, system integration initiatives projects at site level.
• Ensure seamless integration between IT/OT, L2 Systems and data historian systems to enable reliable production data flow and business visibility.
• Manage user access, system security, backup, restoration and data integrity controls for manufacturing systems.
• Support Computerized System Validation (CSV), qualification, change control, and lifecycle management of GxP-regulated systems.
• Maintain infrastructure connected to manufacturing equipment and automation platforms.
• Ensure compliance with corporate IT policies, site SOPs, Data Integrity requirements, 21 CFR Part 11 and GAMP 5 guidelines.
• Coordinate with Engineering, Production, Quality, Corporate IT and OEM to ensure high system availability and operational excellence.
• Prepare and maintain SOPs, validation documents, protocols, reports, and technical documentation.
• Support regulatory inspections, audits, and continuous improvement initiatives.
• Conduct periodic user access reviews, audit trail reviews, active user reviews, and date/time verification of regulated systems.
• Implement and support OT security controls to protect manufacturing and automation environments.
• Strong written and verbal communication skills to effectively engage stakeholders and collaborate across cross-functional teams.

Need Based

Job Scope

Internal Interactions (within the organization)

Plant Management, Business Users, Corporate IT Teams, Quality and CSV Teams

External Interactions (outside the organization)

Geographical Scope

Directly Manage site IT operation and at the same time provide onsite / offsite support to another site whenever needed.

Financial Accountability (cost/revenue with exclusive authority)

Support based on Approved Budgets for the sites – Both Opex & Capex

Job Requirements

Educational Qualification

Bachelor's degree in Computer Science, Electronics, Instrumentation, Automation Engineering, or related discipline

Skills

SCADA, PLC, CSV, GAMP 5, Data Integrity (ALCOA+), OT Security, Computerized System Validation (CSV), 21 CFR Part 11 & EU Annex 11 Compliance, Pharma Manufacturing Systems, Regulatory Compliance.

Experience with MES systems will be considered an added advantage.

Experience

05-08 Years in IT Operations, Preferably in Pharma Manufacturing (Injectable & OSD)

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

• We provide robust benefits and opportunities to foster personal and professional growth.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).