Sr Executive- Mfg Informatics

SUN PHARMA; Baksa; On-site; INR 1,800,000 - 2,200,000; Full time

Job summary

Sun Pharma is seeking an experienced professional to lead and support Manufacturing Informatics, MES, OT, and digital manufacturing systems operations in a GxP environment. You will ensure system availability, validation, security, and lifecycle management of IT/OT infrastructure and applications.

You will drive CSV validation, data integrity, system integrations, and continuous improvement while collaborating with Quality, Production and Regulatory teams to meet compliance and operational

Qualifications

• Bachelor’s degree in Computer Science, Electronics, Instrumentation, Automation Engineering, or related discipline.
• Experience with MES systems is a plus.

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.
• Support CSV validation, change control and data integrity for GxP-regulated systems.
• Coordinate IT/OT integration and data historian interfacing for real-time production data.
• Prepare SOPs, validation protocols and regulatory documentation.
• Support regulatory inspections and continuous improvement initiatives.

Skills

SCADA

PLC

CSV

GAMP 5

Data Integrity

OT Security

23 CFR Part 11

EU Annex 11

Pharma Systems

Regulatory Compliance

Education

Bachelors in CS/Engineering/Instrumentation

Tools

MES systems

Job description

Job Description:

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.

Travel Estimate

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)

Various Service providers, Vendors, Customers, Regulatory Auditors.

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

Bachelors 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!

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).