MES Specialist - Drug Product/ Sterile Operations

Job Description

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.

Qualifications

Education

• Bachelor’s degree in Engineering, Computer Science, Information Technology, or a related field.

Experience

• 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.

Additional Information

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 robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
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.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/