Description :
Education Qualification :
Bachelor’s degree Science or Engineering related to IT\Computer Science\Electronics\Instrumentation\Pharmacy
Professional Experience & Responsibilities :
- Minimum experience of 4+ years on MES application AspenTech V11, V12 and V14
- Having good hold on Kepware OPC, Aspen Manufacturing Suite V11, V12 and V14 (Aspentech Infoplus.21 Plant Historian, Aspen Layered Products & Client tools, APRM - Aspen Production Records Manager (Batch Historian – Batch 21), APEM - Aspen Production Execution Manager (eBRS), Werum PAS-X 3.1.8, PAS-X 3.2 and Siemens Opcenter MES.
- Proven track record of leading, driving and successfully closing IT projects in a complex, global matrix organization and proven ability to lead teams.
- You should also be able to act proactively to ensure smooth team operations and effective collaboration.
- Having good knowledge on PAS-X functionality like weighing & dispensing module, equipment management, MBR design and EBR and materials management / warehouse functionality
- Should have knowledge on System Administration activities like User / Terminal / Printers Management and system configuration
- Have knowledge on MES integration with Level 2, Level 3 and Level 4 systems like SAP ERP, OSI PI, LIMS.
- Familiar with current manufacturing models and concepts in Life Science and Healthcare and proven track record in Pharmaceutical GxP project implementation and validation
- Understanding of ISA88 and ISA95 standards
- Knowledge on Computer Systems Validation, SDLC methodologies, 21CFR part 11, and cGMP including GAMP and EU Annex 11
- Have experience on new implementation and upgrade projects from requirement gathering stage to qualification and final delivery of MES
- Responsible for delivery of various ITSM services like Incident Management, problem Management, Change and Release management etc.
- Experience on Databases like Oracle and Microsoft SQL server is an advantage
- Formal qualification in PMP, ITIL are a plus
- Excellent communication and collaboration skills