CSV Analyst with Instrument integration & Validation expertise

Title: CSV Analyst with Instrument integration & Validation expertise

Location: Cincinnati OH (Onsite)

Type: Contract

• 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.
• we are looking for 4 6 contract-to-hire resources to perform following. These resources do not need to be located in Highland Heights KY or Brussels Belgium.
• 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:

• Bachelors 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