CSV Support Engineer

Job Title

CSV Support Engineer –
Katalyst CRO

Greenfield, IN – Remote / On‑site acceptable.

We seek 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, 21 CFR Part 11, and related regulatory requirements. The role also involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems.

• Administer Empower CDS: user accounts, roles, access rights, and system configuration.
• Provide day‑to‑day L2/L3 support for Empower users across QC and analytical laboratories.
• Integrate laboratory instruments (HPLC, UPLC, GC, dissolution, UV, etc.) with Empower and troubleshoot connectivity and data acquisition issues.
• Collaborate with vendors (Waters, Agilent, Thermo) to resolve technical problems.
• Lead Computer System Validation activities: develop and maintain URS, FS, DS, IQ, OQ, PQ, test scripts, and traceability matrices.
• Ensure compliance with GxP, 21 CFR Part 11, Annex 11, ALCOA+, 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 align system changes with regulatory requirements.
• Collaborate with QA, IT, and Lab teams on change control and deviation management.
• Train and mentor lab users on Empower functionalities and best practices.
• Propose process improvements for data integrity, system efficiency, and compliance.

• Bachelor’s degree in a relevant field.
• 8–12 years of experience with Empower CDS administration and support.
• Minimum 3 years’ experience in HPLC/UPLC/GC and analytical instrument integration.
• Minimum 3 years’ experience in Computer System Validation (CSV) and preparation of validation deliverables.
• At least 1 year of experience with GxP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.
• Strong communication skills and ability to provide constructive feedback.
• Experience with Agile/Scrum practices and tools such as Jira or Azure Dev Ops is a plus.
• Exposure to other CDS/LIMS/ELN systems and regulated environments (Pharma, Biotech, Medical Devices) is advantageous.

• SQL/Oracle database knowledge.
• Networking concepts and IT infrastructure familiarity.
• Ability to write clear documentation and test scripts.
• Strong troubleshooting, analytical, and problem‑solving skills.

Contract – Full‑time (subject to negotiation).

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