Post a Job

Millions Of Active Candidates

For Employers

VIEW SIMILAR JOBS →

Loading, Please wait..!!

CSV Analyst

Posted on: Oct 28, 2026

Katalyst Healthcares & Life Sciences
Saint Paul, Minnesota
Onsite
Full-time

Save this job

Apply Here APPLY LATER

Curious about compensation?

Explore the historical salary trends, average pay, and estimated compensation for CSV Analyst roles in Minnesota.

View Salary Guide →

Over 12 millions jobs on Snaprecruit.
Find your match !

VIEW SIMILAR JOBS →

Job Title :

CSV Analyst

Job Type :

Full-Time

Job Location :

Saint Paul Minnesota United States

Remote :

Job Description :

View Full Description

Job Description

Job Description:

We are seeking a CSV Analyst with Instrument Integration & Validation expertise to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments.
The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows.
This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements.

Roles & Responsibilities:

Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
Develop and execute validation protocols including IQ, OQ, and PQ.
Ensure systems remain in a validated state throughout their lifecycle.
Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices.
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
Gather and document system requirements.
Develop software specifications, validation test cases, and supporting documentation.
Create infrastructure diagrams, data flow diagrams, and document current system configurations.
Perform functional, integration, regression, and data integrity testing.
Identify, document, and troubleshoot validation deviations.
Conduct root cause analysis and collaborate with cross-functional teams for issue resolution.
Conduct risk assessments (FMEA) to identify and mitigate system risks.
Support change control processes for software updates and enhancements.
Assist in transitioning legacy SOPs to updated IT/software management SOPs.
Perform regulated laboratory validation activities.
Support requirements gathering and documentation.
Author and execute validation test cases.
Perform IQ/OQ/PQ, UAT, and end-to-end testing.
Conduct risk assessments and support change control activities.
Perform technical writing and objective evidence collection.
Verify data integrity across systems.
Support instrument integration workflows.
Work with Instrument Manager or similar middleware.
Validate instrument-to-middleware-to-LIS data flow.
Support LIS, downstream reporting, and QC-related workflows.
Ensure alignment with CAP, CLIA, 21 CFR Part 11, and GAMP risk-based validation expectations.

Requirements:

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
2 5 years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical device industries.
Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5.
Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower).
Experience with validation lifecycle processes, documentation standards, and data integrity principles.
Strong regulated laboratory validation experience in Instrument Integration & Validation.

Position Details

Posted:

Oct 28, 2026

Reference Number:

56b63f63

Employment:

Full-time

City:

Saint Paul

Job Origin:

ziprecruiter

Share this job:

CSV Analyst Apply

Click on the below icons to share this job to Linkedin, Twitter!

Job Description

Job Description:

We are seeking a CSV Analyst with Instrument Integration & Validation expertise to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments.
The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows.
This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements.

Roles & Responsibilities:

Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
Develop and execute validation protocols including IQ, OQ, and PQ.
Ensure systems remain in a validated state throughout their lifecycle.
Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices.
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
Gather and document system requirements.
Develop software specifications, validation test cases, and supporting documentation.
Create infrastructure diagrams, data flow diagrams, and document current system configurations.
Perform functional, integration, regression, and data integrity testing.
Identify, document, and troubleshoot validation deviations.
Conduct root cause analysis and collaborate with cross-functional teams for issue resolution.
Conduct risk assessments (FMEA) to identify and mitigate system risks.
Support change control processes for software updates and enhancements.
Assist in transitioning legacy SOPs to updated IT/software management SOPs.
Perform regulated laboratory validation activities.
Support requirements gathering and documentation.
Author and execute validation test cases.
Perform IQ/OQ/PQ, UAT, and end-to-end testing.
Conduct risk assessments and support change control activities.
Perform technical writing and objective evidence collection.
Verify data integrity across systems.
Support instrument integration workflows.
Work with Instrument Manager or similar middleware.
Validate instrument-to-middleware-to-LIS data flow.
Support LIS, downstream reporting, and QC-related workflows.
Ensure alignment with CAP, CLIA, 21 CFR Part 11, and GAMP risk-based validation expectations.

Requirements:

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
2 5 years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical device industries.
Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5.
Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower).
Experience with validation lifecycle processes, documentation standards, and data integrity principles.
Strong regulated laboratory validation experience in Instrument Integration & Validation.

Please wait..!!

Millions Of Active Candidates

CSV Analyst