Working as a process automation Engineer for one of the largest pharmaceutical project in Europe.

✓ Working as a process automation engineer and have experience in ISA 88 Batch Standards, Batch Design and Batch system programming.✓ Development in 800Xa Recipe Management and Procedures as applicable to Batch Production process✓ Executing Pharma projects from BD to commissioning stage. ✓ ABB 800Xa skills: • CM, EM, Phases and Procedures • HMI and Graphic Design • PCDL and Core Library • SFC with ST language • BDM Tool • 800Xa SIS Interface and testing • MES PAS-X Interface and testing • Using MMS, IAC Communication • Recipe development in the procedure structure OP, UP and RP.✓ Using a TIMS application for Electronic validation FAT, SAT and UAT as per GAMP5.✓ Using a PIMS application for change management.

✓ Prepare the CQV and CSV deliverables for process equipment’s such as VAR, GxP assessment, ER-ES Assessment, Validation Plan, FRA, RTM, DQ, IQ and OQ. ✓ Reviewing the vendor design documents for process equipment’s such as P&ID, GA, BOM and technical data sheet and CSV documents. ✓ Involved fully automated equipment qualification such as fermenters, peptide synthesizer, process vessel, Liquid chromatography, centrifuge and DCS.✓ knowledge in ISPE Base guide Volume 5, GAMP 5 with V-Model approach and 21 CFR Part 11 and EU annexure 11 guidelines.

✓Biological process with hands-on experience to handle the process equipment with fully automated systems bioreactor,Media, CIP systems...✓Involved in Process equipment commissioning and qualification activity .✓Handsone experience to prepare the process equipment FS with ISA 88 standard..✓Review the process equipment design with reference to ADMEBPE Standard.✓ Good knowledge in Quality Management System (QMS) handling (SOP, Deviation, IR, CAPA and CCF).✓Knowledge in Process automation system and hands-on experience in Siemens PCS7 with Batch application..

✓ Process Engineer..✓ Review the process flow diagram for process equipment with respect to the FS...