Dotnet Technical Manager

MES Apriso Developer :-

Core Technical & Domain Expertise

• 2 to 10 years of hands-on experience in e BMR / MES implementation within regulated pharmaceutical or life sciences environments
• Proven expertise in end-to-end e BMR lifecycle including design, configuration, execution, review by exception (RBE), and batch release
• Deep understanding of pharmaceutical manufacturing processes (Dispensing, Weighing, Granulation, Compression, Coating, Packing, Sterile / Non-sterile operations)
• Strong experience working with MES/e BMR or equivalent enterprise MES platforms (We rum PAS-X, Siemens OpsCenter, Rockwell FactoryTalk, etc.)

Regulatory & Validation Expertise

• Expert-level knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, WHO, MHRA, USFDA expectations
• Extensive experience in Computer System Validation (CSV) for MES/e BMR systems
• Ability to independently author, review, and approve URS, FS, DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix
• Experience handling data integrity requirements (ALCOA+) and audit trail reviews
• Direct involvement in regulatory audits and inspections, responding to observations and CAPAs related to MES/e BMR systems

System Architecture & Integration Skills

• Strong knowledge of MES architecture, batch orchestration, master data management, and exception handling
• Hands-on experience integrating MES/e BMR with:
• ERP systems (SAP, Oracle)
• LIMS, QMS, DMS
• Automation systems (PLC, SCADA, DCS)
• Working knowledge of REST APIs, web services, databases, and middleware
• Ability to troubleshoot complex interface, performance, and data consistency issues

Interested Candidates Please share your Updated resume to avinash.r@amplelogic.com