CDS EMPOWER Administrator / Application Support

Job description

Job Description **Role:** CDS EMPOWER Administrator / Application Support **Required Technical Skill Set:** CDS EMPOWER Administrator professional responsible for managing, supporting, configuring, and maintaining Waters Empower Chromatography Data System (CDS) in a regulated GxP environment. The role ensures system availability, user administration, instrument connectivity, data integrity, compliance, and support for laboratory operations while collaborating with QA, QC, Validation, and IT teams. **Desired Experience Range** : 4–6years **Location of Requirement** : PAN India **Desired Competencies** Must-Have **Functional** - Strong understanding of Chromatography Data Systems (CDS) and laboratory workflows. - Experience in Empower Administration and Application Support. - Knowledge of pharmaceutical QC laboratory processes. - Experience in Incident, Problem, Change, and Service Request Management. - Understanding GxP, FDA, ALCOA+, and Data Integrity requirements. - Experience supporting audit and regulatory inspections. - Strong stakeholder management and communication skills. **Technical** - Hands-on experience with Waters Empower 3 Administration. - User, Group, Role, and Privilege Management. - Instrument integration and node configuration. - Project creation and management. - Backup, restore, and disaster recovery support. - Experience supporting Empower upgrades, patches, and migrations. - Audit trail review and data integrity monitoring. - Knowledge of Oracle and SQL databases. - Experience with Empower Security Management. - Troubleshooting instrument connectivity and application issues. - Basic Windows Server administration knowledge. - Familiarity with Active Directory integration. **Specific Skills and Expertise:** - Strong troubleshooting and root-cause analysis skills. - Ability to manage multiple priorities and support activities. - Experience creating SOPs, work instructions, and technical documentation. - Good understanding of laboratory systems validation. - Effective collaboration with global teams and vendors. **General** - Strong analytical and problem-solving skills. - Compliance-focused mindset. - Attention to detail and accuracy. - Ability to work independently and in team environments. - Customer-focused approach with strong communication skills. Good-to-Have - Experience in Pharmaceutical/Life Sciences domain. - Knowledge of Computer System Validation (CSV). - Understanding 21 CFR Part 11 requirements. - Exposure to Empower Method Validation and Qualification activities. - Experience with LIMS, ELN, SDMS, or other laboratory systems. - Knowledge of ITIL processes. - Experience supporting cloud or virtualized environments. - Water Empower certification. Background - Bachelor's degree in computer science, Information Technology, Life Sciences, Pharmacy, Chemistry, and related fields. - 4–6 years of experience in Waters Empower Administration, CDS Support, or Laboratory Informatics Applications. - Experience in regulated pharmaceutical or biotechnology environments preferred. **Responsibility of / Expectations from the Role** - Provide L2/L3 support for Waters Empower application and infrastructure. - Manage user accounts, groups, roles, and security permissions. - Configure and maintain Empower projects and repositories. - Support instrument integration and connectivity troubleshooting. - Handle incidents, service requests, and change activities. - Monitor application of health, performance, and availability. - Perform backup, restore, and disaster recovery activities. - Support Empower upgrades, patches, and system migrations. - Ensure compliance with GxP, 21 CFR Part 11, and Data Integrity requirements. - Review and maintain audit trails and security controls. - Prepare and maintain SOPs, validation documents, and support records. - Coordinate with laboratory users, QA, vendors, and IT teams for issue resolution. - Support qualification, validation, and periodic review activities. - Participate in inspections, audits, and compliance assessments.