Ecocareers ยท 3 months ago
CSV Support Engineer
Greenfield, IN
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expEcocareers is a company focused on laboratory informatics solutions, and they are seeking a CSV Support Engineer to manage and support Waters Empower Chromatography Data System (CDS). The role involves overseeing laboratory instrument integration, performing troubleshooting, and ensuring system compliance with GxP and 21 CFR Part 11 regulatory requirements.
Staffing & Recruiting
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
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
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
Qualification
Required
Any bachelor's degree Experience Range 8-12 years
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
Preferred
Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase