Role : CSV Analyst with Instrument integration & Validation expertise
Location : Cincinnati, Ohio
We are seeking a 10+ Yrs. of strong regulated lab validation experience in Instrument integration & Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments to the integration layer — confirming that data moves accurately and completely from the instrument, through Instrument Manager, into the LIS, and through any related downstream workflows.
The role ensures systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance.
- Regulated laboratory validation
- Requirements gathering and documentation
- Validation test case authoring and execution
- IQ/OQ/PQ, UAT, and end-to-end testing
- Risk assessments and change control
- Technical writing and objective evidence collection
- Data integrity verification across systems
- Instrument integration workflows
- Instrument Manager or similar middleware
- Instrument-to-middleware-to-LIS data flow
- LIS, downstream reporting, and QC-related workflows
- CAP, CLIA, 21 CFR Part 11, and GAMP / risk-based validation expectations
Roles & Responsibilities:
Software Validation & Compliance
- 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
Documentation & Regulatory Support
- 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
System Analysis & Design
- 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
Testing & Execution
- 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
Risk & Change Management
- 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
Education & Experience:
- 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
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