Jobs via Dice
Empower CDS administration/ support ( W2 Position)
Jobs via Dice, Greenfield, Indiana, United States, 46140
Overview
Empower CDS administration/ support (W2 Position). This role focuses on managing and supporting Waters Empower Chromatography Data System (CDS), instrument integration, troubleshooting, and ensuring system compliance with GxP and 21 CFR Part 11 regulatory requirements. The position involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems. Responsibilities
Empower Administration & Support: 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, 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. Training & Continuous Improvement: Train and mentor lab users on Empower functionalities and best practices; propose process improvements for data integrity, system efficiency, and compliance. Soft Skills & Other Qualifications
Communication Skills: Communicate effectively with internal and customer stakeholders; proficient in verbal communication, emails, and instant messages; strong interpersonal skills to build and maintain productive relationships; provide constructive feedback during code reviews and be open to receiving feedback. Problem-Solving & Analytical Thinking: Strong troubleshooting and analytical abilities; analytical mindset; experience in working on Agile/Scrum projects with exposure to Jira/Azure DevOps; ability to provide regular updates and proactive, due-diligent responsibilities. Technical & Domain Knowledge: Familiarity with GxP, 21 CFR Part 11, Annex 11, ALCOA+ Data Integrity principles; exposure to CDS/LIMS/ELN systems; experience in regulated environments (Pharma, Biotech, Medical Devices); familiarity with networking concepts, SQL/Oracle databases, or IT infrastructure. Qualifications
Educational Qualification: Any Bachelor's Degree Experience Range: 8-12 years Primary (Must have skills): 3+ years of hands-on Empower CDS administration and support; 3+ years of experience on HPLC/UPLC and other analytical instrument integration; 3+ years of experience on CSV and validation deliverables; 1+ year on GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and Data Integrity requirements. Other: 5+ years preferred demonstrating experience across Empower CDS, instrument integration, validation, and compliance in regulated environments.
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Empower CDS administration/ support (W2 Position). This role focuses on managing and supporting Waters Empower Chromatography Data System (CDS), instrument integration, troubleshooting, and ensuring system compliance with GxP and 21 CFR Part 11 regulatory requirements. The position involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems. Responsibilities
Empower Administration & Support: 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, 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. Training & Continuous Improvement: Train and mentor lab users on Empower functionalities and best practices; propose process improvements for data integrity, system efficiency, and compliance. Soft Skills & Other Qualifications
Communication Skills: Communicate effectively with internal and customer stakeholders; proficient in verbal communication, emails, and instant messages; strong interpersonal skills to build and maintain productive relationships; provide constructive feedback during code reviews and be open to receiving feedback. Problem-Solving & Analytical Thinking: Strong troubleshooting and analytical abilities; analytical mindset; experience in working on Agile/Scrum projects with exposure to Jira/Azure DevOps; ability to provide regular updates and proactive, due-diligent responsibilities. Technical & Domain Knowledge: Familiarity with GxP, 21 CFR Part 11, Annex 11, ALCOA+ Data Integrity principles; exposure to CDS/LIMS/ELN systems; experience in regulated environments (Pharma, Biotech, Medical Devices); familiarity with networking concepts, SQL/Oracle databases, or IT infrastructure. Qualifications
Educational Qualification: Any Bachelor's Degree Experience Range: 8-12 years Primary (Must have skills): 3+ years of hands-on Empower CDS administration and support; 3+ years of experience on HPLC/UPLC and other analytical instrument integration; 3+ years of experience on CSV and validation deliverables; 1+ year on GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and Data Integrity requirements. Other: 5+ years preferred demonstrating experience across Empower CDS, instrument integration, validation, and compliance in regulated environments.
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