MES Specialist - Drug Product/ Sterile Operations

Requirements

• 4-8 years of experience supporting or implementing MES in a pharmaceutical, biotech, or regulated manufacturing environment.
• Hands‑on experience with manufacturing processes (e.g., formulation, filling, packaging).
• Experience working in GMP and validated system environments.
• Technical Skills
• Strong knowledge of MES.
• Experience with SAP integration, automation systems (PLC/SCADA), and databases.
• Soft Skills
• Strong analytical and problem‑solving skills.
• Excellent communication and cross‑functional collaboration abilities.
• Ability to work independently in a fast‑paced manufacturing environment.
• Strong documentation and stakeholder management skills.
• About the Department
• Biologics
• Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon.
• With a Product Development engine that has end-to-end capabilities - in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
• Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
• We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
• Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.
• Benefits Offered
• At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
• Our Work Culture
• For more details, please visit our career website at https://careers.drreddys.com/#!/

Benefits

Additional Information

The MES Specialist is responsible for the implementation, configuration, maintenance, and support of Manufacturing Execution Systems (MES) to enable compliant, efficient, and paperless manufacturing operations. The role ensures seamless integration between shop‑floor equipment, SAP systems, and quality systems while maintaining data integrity, regulatory compliance, and operational excellence in a GMP environment. To Work in shift operation as per production schedule. Responsible to configure, deploy, and support MES applications. Create and maintain Electronic Batch Records (EBR), master recipes, workflows, and system parameters. Perform MES change management including configuration changes, upgrades, and patch installations. Ensure MES compliance with GxP, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles. Support CSV activities including URS, FRS, DS, IQ, OQ, PQ, and risk assessments. Participate in internal and external audits and inspections related to MES. Prepare and maintain SOPs, work instructions, configuration specifications, and technical documentation. Conduct MES training for shop‑floor users and system administrators. Support deviation investigations, CAPAs, and change controls related to MES. Identify opportunities for process automation, paperless manufacturing, and digital maturity improvements. Drive MES performance optimization and best practices adoption. Support data analytics and reporting initiatives for manufacturing KPIs. Education Bachelor's degree in Engineering, Computer Science, Information Technology, or a related field.

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