CSV Validation Specialist: Instrument Integration

Creative Solutions Services, LLC

Bridgeport (CT)

On-site

USD 90,000 - 120,000

Full time

10 days ago

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Job summary

Creative Solutions Services, LLC 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 ensuring data moves accurately from instruments through Instrument Manager into the LIS and related downstream workflows, bridging software validation, testing, and regulatory compliance to keep systems validated under EMA and GxP requirements.

Qualifications

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).

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 (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 and validation test cases.
Create infrastructure diagrams, data flow diagrams, and document current system configurations.
Perform functional, integration, regression, and data integrity testing.