CSV Analyst with Instrument integration & Validation expertise

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

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., * 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