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Instrumentation Software Validation Analyst

Karwell Technologies

Cincinnati, OH

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JOB DETAILS
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Change Control, Change Management, Chromatographic Systems, Code of Federal Regulations, Computer Science, Computer Skills, Computer Systems, Cross-Functional, Data Quality, Documentation, Documentation Standards, Embedded Software, Embedded Systems, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), Functional Testing, GMP (Good Manufacturing Practices), GxP, Identify Issues, Information Technology Software, Instrumentation, Integration Testing, Laboratory, Laboratory Information Management System (LIMS), Laboratory Systems, Maintain Compliance, Manufacturing, Manufacturing Software, Medical Equipment, Problem Solving Skills, Process Validation, Regression Testing, Regulatory Compliance, Requirements Management, Risk Analysis, Risk Management, Root Cause Analysis, Software Administration, Software Development, Software Specification, Software Testing, Software Validation, Standard Operating Procedures (SOP), System Operations, System Validation, Technical/Engineering Design, Test Case, Traceability, Validation Documentation, Validation Plan, Validation Testing, Writing Skills
LOCATION
Cincinnati, OH
POSTED
30+ days ago
Job Description:
We are seeking an experienced Instrument Software Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments. The role ensures systems operate reliably and remain in a validated state in accordance with FDA, EMA, and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance.
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.
Requirements:
  • 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.

About the Company

K

Karwell Technologies

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