Instrument Integration & Validation Specialist

Katalyst CRO; Saint Paul (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a CSV Analyst specializing in Instrument Integration & Validation to ensure validated state of laboratory, manufacturing, and embedded software systems in regulated environments.

The role bridges software validation, testing, and regulatory compliance, ensuring data moves accurately from instruments to LIS and downstream workflows in compliance with EMA, FDA, and GxP guidelines. You will author validation documentation and support lifecycle activities.

Qualifications

• Bachelor's degree in a relevant discipline (e.g., CS, Engineering, Life Sciences).
• 25+ years in CSV or software validation within pharma/biotech/medical devices.
• Strong knowledge of FDA/EMA/GxP regulations and 21 CFR Part 11.
• Experience with LIMS and Chromatography Data Systems.
• Proven record creating validation docs and risk assessments.

Responsibilities

• Validate laboratory and manufacturing software in regulated environments.
• Develop IQ/OQ/PQ protocols and execute validation testing.
• Maintain validation state across systems through lifecycle.
• Prepare validation plans, reports, URS, specs, and traceability matrices.
• Support change control and regulatory compliance activities.

Skills

Instrument integration

Software validation

IQ/OQ/PQ

Data integrity

Regulatory compliance

FMEA risk

GxP awareness

Education

Bachelor's degree

Tools

LIMS

Empower

Instrument Manager

CFR 21 Part 11

Job description

Katalyst CRO is seeking a CSV Analyst specializing in Instrument Integration & Validation to ensure validated state of laboratory, manufacturing, and embedded software systems in regulated environments.

The role bridges software validation, testing, and regulatory compliance, ensuring data moves accurately from instruments to LIS and downstream workflows in compliance with EMA, FDA, and GxP guidelines. You will author validation documentation and support lifecycle activities.