MES engineer- Empower
Posted Updated
Summary
MES engineer administering and supporting Empower CDS systems in a regulated (pharma/chemical) lab environment: end-user support, server maintenance, backups, deployments, lab software validation, and 21 CFR Part 11/GxP compliance documentation. Based primarily in Bangalore, with Pune as an alternative.
MES engineer- Empower
"""we would
need these resources to be based out of primarily Bangalore or Pune as an
alternative location
""""• Strong Technical Knowledge on Empower & other CDS Systems
• Maintaining and supporting current CDS system
• End user issue support, troubleshooting, & resolution
• Administration of CDS system and server maintenance
• Backup, archival, restore and periodic review of system
• Support in deployment/Installation of CDS applications
• Complete knowledge on user management of lab applications
• Coordinate with multiple instrument vendor during application/instrument setup and instrument qualification
• Hand-holds Site SME’s in Empower operations and implementations through proper training and support
• Experience working in a Pharmaceuticals, Chemical, Manufacturing or any regulated environment....
• Excellent verbal and written communications skills
• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols
• Data integrity and compliance to 21CFR Part 11 and GxP standards
• Prepare draft and final SOPs and compliance documents
""""• Strong Technical Knowledge on Empower & other CDS Systems
• Maintaining and supporting current CDS system
• End user issue support, troubleshooting, & resolution
• Administration of CDS system and server maintenance
• Backup, archival, restore and periodic review of system
• Support in deployment/Installation of CDS applications
• Complete knowledge on user management of lab applications
• Coordinate with multiple instrument vendor during application/instrument setup and instrument qualification
• Hand-holds Site SME’s in Empower operations and implementations through proper training and support
• Experience working in a Pharmaceuticals, Chemical, Manufacturing or any regulated environment....
• Excellent verbal and written communications skills
• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols
• Data integrity and compliance to 21CFR Part 11 and GxP standards
• Prepare draft and final SOPs and compliance documents
Requirements
MES engineer- Empower
"""we would
need these resources to be based out of primarily Bangalore or Pune as an
alternative location
""""• Strong Technical Knowledge on Empower & other CDS Systems
• Maintaining and supporting current CDS system
• End user issue support, troubleshooting, & resolution
• Administration of CDS system and server maintenance
• Backup, archival, restore and periodic review of system
• Support in deployment/Installation of CDS applications
• Complete knowledge on user management of lab applications
• Coordinate with multiple instrument vendor during application/instrument setup and instrument qualification
• Hand-holds Site SME’s in Empower operations and implementations through proper training and support
• Experience working in a Pharmaceuticals, Chemical, Manufacturing or any regulated environment....
• Excellent verbal and written communications skills
• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols
• Data integrity and compliance to 21CFR Part 11 and GxP standards
• Prepare draft and final SOPs and compliance documents
""""• Strong Technical Knowledge on Empower & other CDS Systems
• Maintaining and supporting current CDS system
• End user issue support, troubleshooting, & resolution
• Administration of CDS system and server maintenance
• Backup, archival, restore and periodic review of system
• Support in deployment/Installation of CDS applications
• Complete knowledge on user management of lab applications
• Coordinate with multiple instrument vendor during application/instrument setup and instrument qualification
• Hand-holds Site SME’s in Empower operations and implementations through proper training and support
• Experience working in a Pharmaceuticals, Chemical, Manufacturing or any regulated environment....
• Excellent verbal and written communications skills
• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols
• Data integrity and compliance to 21CFR Part 11 and GxP standards
• Prepare draft and final SOPs and compliance documents