CSV Analyst - Cincinnati, OH

[Sid K]

Hi Folks. 

My client is looking for CSV Analyst for 5 Month Contract role based in Cincinnati, OH

 

Position: CSV Analyst

Location:  Cincinnati, OH

Duration: 5 Month Contract

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
  
  Thanks
  Sid