SaaS COTS (Empower Administration - Lab Systems & Compliance )

Job Title: SaaS COTS (Empower Administration - Lab Systems & Compliance ) Location: Hybrid Indianapolis – Visit office twice in the month Job Type: Contract to hire Job Description: Experience 10 to 20 yrs Educational Qualification • Any Bachelor's Degree Experience Range 8-10 years Primary (Must have skills) • - To be Screened by TA Team 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. Job Description of Role • (RNR) - To be Evaluated by Technical Panel (Define it to give more clarity) Key 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, 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. 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 skills - To be Evaluated by Hiring Manager (To define how this will be evaluated) Communication Skills: Communicate effectively with internal and customer stakeholders. Communication approach: verbal, emails and instant messages. Interpersonal Skills: Strong interpersonal skills to build and maintain productive relationships with team members. Provide constructive feedback during code reviews and be open to receiving feedback on your own code. Problem-Solving and Analytical Thinking: Capability to troubleshoot and resolve issues efficiently. Analytical mindset Task/ Work Updates Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps. Provides regular updates, proactive and due diligent to carry out responsibilities. Expected Outcome We are seeking an experienced professional to manage and support Waters Empower Chromatography Data System (CDS), oversee laboratory instrument integration, perform troubleshooting, and ensure system compliance with GxP and 21 CFR Part 11 regulatory requirements. The role also involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems. Secondary Skills to be planned Post Hiring - Training Plan Strong troubleshooting, analytical, and problem-solving skills. Excellent documentation, communication, and cross-functional collaboration abilities. Exposure to other CDS/LIMS/ELN systems. Experience in regulated environments (Pharma, Biotech, Medical Devices). Familiarity with networking concepts, SQL/Oracle databases, or IT infrastructure.