MES Specialist - Drug Product/ Sterile Operations

Job Description:

Responsibilities

• 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.

Qualification & 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.
• Strong knowledge of MES.
• Experience with SAP integration, automation systems (PLC/SCADA), and databases.
• 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.