CSV Validation Specialist: Instrument Integration

Katalyst CRO; Bridgeport (CT); In loco; USD 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is 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, while maintaining validated state per EMA/GxP requirements.

Competenze

• Bachelor's degree in a scientific or engineering field.
• Experience validating laboratory/software systems in regulated environments.
• Strong knowledge of FDA/EMA/GxP and 21 CFR Part 11 requirements.
• Proven ability to develop and execute IQ/OQ/PQ validation protocols and associated documentation.

Mansioni

• Validate software used in laboratory and manufacturing instruments per FDA/EMA/GxP guidelines.
• Develop and execute validation protocols including IQ, OQ, PQ and UAT.
• Maintain and update Validation Plans, Reports, URS, Functional/Design Specs, and Traceability Matrices.
• Ensure data integrity across systems and manage risk assessments (FMEA).
• Support change control processes for software updates and enhancements.
• Collaborate with cross-functional teams to resolve validation deviations and document root cause analyses.

Conoscenze

Instrument Integration

Software Validation

Data Integrity

Regulatory Compliance

Test Protocols (IQ/OQ/PQ)

Root Cause Analysis

UAT Testing

Formazione

Bachelor's degree in a STEM field

Strumenti

LIMS

Empower

Instrument Manager

Descrizione del lavoro

Katalyst CRO is 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, while maintaining validated state per EMA/GxP requirements.