IT Support Analyst
I-Flow
Job Title: IT Support Analyst - Empower:
Location: ~Boston, MA~ Onsite
Duration: 6 months
Experience:6-8 Years Job Description:
Waters Empower application support, Empower administration, L1/L2/L3 AMS support, incident management, change management, problem management, ITIL processes, user access management, roles/privileges, project creation, sample set/sample creation, batch creation, instrument connectivity, instrument integration, acquisition nodes, client/server troubleshooting, chromatography data systems, chromatographic integration, GxP, 21 CFR Part 11, data integrity, audit trails, CSV/validation documentation, SOP adherence, multi-site pharma support, pharma domain experience, quality standards, stakeholder coordination, SLA management, and support documentation. Roles & Responsibilities
• Provide day-to-day AMS support for Waters Empower application across multiple pharmaceutical manufacturing, QC, R&D, and laboratory sites.
• Handle L1/L2/L3 application support activities including incident triage, troubleshooting, resolution, escalation, and user communication as per defined SLA and ITIL processes.
• Support Empower administration activities such as user access management, roles/privileges, project creation, instrument/system configuration, audit trail review support, and routine application maintenance.
• Coordinate with site laboratory teams, business users, infrastructure teams, network teams, database teams, vendors, and global application owners for issue resolution and operational continuity.
• Support Empower client/server components, interfaces, instrument connectivity, instrument integration, acquisition nodes, sample set/sample creation, batch creation and batch Management, processing methods, chromatographic integration, reports, and data review workflows as applicable to site operations.
• Perform root cause analysis for recurring incidents, identify preventive actions, and drive problem management to improve system stability and reduce ticket volume.
• Execute and support change management activities including impact assessment, change documentation, testing coordination, deployment support, and post-implementation validation in a GxP environment.
• Ensure compliance with GxP, 21 CFR Part 11, data integrity, audit trail, access control, and computer system validation requirements while supporting Empower application operations.
• Support periodic reviews, access recertification, system health checks, SOP adherence, deviation/CAPA support, and audit readiness activities related to Empower.
• Assist with Empower upgrades, patches, hotfixes, configuration changes, validation testing, regression testing, and documentation updates across global or regional sites.
• Create and maintain support documentation including knowledge articles, SOPs, troubleshooting guides, runbooks, configuration records, and operational handover documents.
• Monitor application availability, ticket trends, SLA performance, recurring issues, and service improvement opportunities for multi-site AMS operations.
• Identify process improvement opportunities across incident handling, ticket triage, recurring issue management, knowledge management, access request handling, and multi-site support operations to improve efficiency and service quality.
• Explore and propose opportunities to use automation and Gen AI for support activities such as ticket summarization, knowledge article creation, SOP/runbook drafting, trend analysis, root cause insights, self-service enablement, and faster incident resolution, while ensuring data privacy, compliance, and validation requirements are met.
• Participate in daily/weekly service reviews, status reporting, incident bridges, major incident support, and stakeholder communications for business-critical issues.
• Support onboarding of new sites, transition activities, hypercare support, knowledge transfer, and standardization of Empower support processes across sites.
• Work in shift-based or extended-hours support model as required to support global pharma operations and ensure timely response to critical laboratory system issues.
Location: ~Boston, MA~ Onsite
Duration: 6 months
Experience:6-8 Years Job Description:
Waters Empower application support, Empower administration, L1/L2/L3 AMS support, incident management, change management, problem management, ITIL processes, user access management, roles/privileges, project creation, sample set/sample creation, batch creation, instrument connectivity, instrument integration, acquisition nodes, client/server troubleshooting, chromatography data systems, chromatographic integration, GxP, 21 CFR Part 11, data integrity, audit trails, CSV/validation documentation, SOP adherence, multi-site pharma support, pharma domain experience, quality standards, stakeholder coordination, SLA management, and support documentation. Roles & Responsibilities
• Provide day-to-day AMS support for Waters Empower application across multiple pharmaceutical manufacturing, QC, R&D, and laboratory sites.
• Handle L1/L2/L3 application support activities including incident triage, troubleshooting, resolution, escalation, and user communication as per defined SLA and ITIL processes.
• Support Empower administration activities such as user access management, roles/privileges, project creation, instrument/system configuration, audit trail review support, and routine application maintenance.
• Coordinate with site laboratory teams, business users, infrastructure teams, network teams, database teams, vendors, and global application owners for issue resolution and operational continuity.
• Support Empower client/server components, interfaces, instrument connectivity, instrument integration, acquisition nodes, sample set/sample creation, batch creation and batch Management, processing methods, chromatographic integration, reports, and data review workflows as applicable to site operations.
• Perform root cause analysis for recurring incidents, identify preventive actions, and drive problem management to improve system stability and reduce ticket volume.
• Execute and support change management activities including impact assessment, change documentation, testing coordination, deployment support, and post-implementation validation in a GxP environment.
• Ensure compliance with GxP, 21 CFR Part 11, data integrity, audit trail, access control, and computer system validation requirements while supporting Empower application operations.
• Support periodic reviews, access recertification, system health checks, SOP adherence, deviation/CAPA support, and audit readiness activities related to Empower.
• Assist with Empower upgrades, patches, hotfixes, configuration changes, validation testing, regression testing, and documentation updates across global or regional sites.
• Create and maintain support documentation including knowledge articles, SOPs, troubleshooting guides, runbooks, configuration records, and operational handover documents.
• Monitor application availability, ticket trends, SLA performance, recurring issues, and service improvement opportunities for multi-site AMS operations.
• Identify process improvement opportunities across incident handling, ticket triage, recurring issue management, knowledge management, access request handling, and multi-site support operations to improve efficiency and service quality.
• Explore and propose opportunities to use automation and Gen AI for support activities such as ticket summarization, knowledge article creation, SOP/runbook drafting, trend analysis, root cause insights, self-service enablement, and faster incident resolution, while ensuring data privacy, compliance, and validation requirements are met.
• Participate in daily/weekly service reviews, status reporting, incident bridges, major incident support, and stakeholder communications for business-critical issues.
• Support onboarding of new sites, transition activities, hypercare support, knowledge transfer, and standardization of Empower support processes across sites.
• Work in shift-based or extended-hours support model as required to support global pharma operations and ensure timely response to critical laboratory system issues.
Vacancy posted 3 days ago
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