MES Specialist Drug Product Sterile Operations

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 shopfloor 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 shopfloor 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

• Bachelors degree in Engineering Computer Science Information Technology or a related field.

Experience

• 48 years of experience supporting or implementing MES in a pharmaceutical biotech or regulated manufacturing environment.
• Handson 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 problemsolving skills.
• Excellent communication and crossfunctional collaboration abilities.
• Ability to work independently in a fastpaced 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 1015-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 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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  Work :

No

Employment Type :

Full-time