CSV Analyst

Katalyst CRO; Saint Paul (MN); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Instrument integration

Software validation

IQ/OQ/PQ

Data integrity

Regulatory compliance

FMEA risk

GxP awareness

Formation

Bachelor's degree

Outils

LIMS

Empower

Instrument Manager

CFR 21 Part 11

Description du poste

• 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.
• 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.
• 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.

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.
• 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.
• 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.

Roles & Responsibilities

• 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.
• 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.
• 25+ 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.