Katalyst CRO ยท 3 months ago
CSV Support Engineer
Greenfield, IN
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst Healthcares & Life Sciences is seeking a CSV Support Engineer to manage and support the Waters Empower Chromatography Data System (CDS) and oversee laboratory instrument integration. The role involves troubleshooting, ensuring compliance with GxP and 21 CFR Part 11 regulatory requirements, and continuous improvement of laboratory informatics systems.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Train and mentor lab users on Empower functionalities and best practices
Propose process improvements for data integrity, system efficiency, and compliance
Communicate effectively with internal and customer stakeholders
Provide constructive feedback during code reviews and be open to receiving feedback on your own code
Capability to troubleshoot and resolve issues efficiently
Provides regular updates, proactive and due diligent to carry out responsibilities
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
Strong interpersonal skills to build and maintain productive relationships with team members
Capability to troubleshoot and resolve issues efficiently
Analytical mindset
Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
Excellent documentation, communication, and cross-functional collaboration abilities
Preferred
Train and mentor lab users on Empower functionalities and best practices
Propose process improvements for data integrity, system efficiency, and compliance
Strong troubleshooting, analytical, and problem-solving skills
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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