Technical Lead – Empower Administration – Lab Systems & Compliance

Location : Greenfields, IN

FTE/Contract

Experience : 8-10 years

Job Description :

• Manage user accounts, access rights, roles, and privileges in Empower.
• Perform system configuration, project management, and template/report customization.
• Provide day-to-day L2/L3 support for Empower users across QC/analytical labs.
• Instrument Integration & Troubleshooting
• Integrate lab instruments (HPLC, UPLC, GC, Dissolution, UV, etc.) with Empower.
• Troubleshoot connectivity, data acquisition, and communication issues between instruments and CDS.
• Work with vendors (e.g., Waters, Agilent, Thermo) for resolution of technical issues.
• System Validation & Compliance
• Support Computer System Validation (CSV) activities for Empower and integrated lab systems.
• Develop and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ, Test Scripts, Traceability Matrix).
• Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs.
• Participate in audits and inspections, providing system and compliance evidence.
• Compliance & Lifecycle Management
• Maintain audit trails, backup, archival, and disaster recovery procedures.
• Conduct periodic system reviews and ensure alignment with regulatory requirements.
• Collaborate with QA, IT, and Lab teams to manage change control and deviations.
• Train and mentor lab users on Empower functionalities and best practices.
• Propose process improvements for data integrity, system efficiency, and compliance.
• 3+ years of hands-on experience in Empower CDS administration and support.
• 3+ years of experience on  HPLC/UPLC/GC and other analytical instrument integration.
• 3+ years of experience on Computer System Validation (CSV) and preparation of validation deliverables.
• 1+ year on GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and Data Integrity requirements.