CSV Consultant

Katalyst Healthcares & Life Sciences

Raritan, NJ

JOB DETAILS
SKILLS
Acceptance Testing, Biotech and Pharmaceutical, Communication Skills, Computer Skills, Computer Systems, Consulting, Documentation, FDA (Food and Drug Administration), GxP, Industry Standards, Maintain Compliance, Medical Equipment, Multitasking, Presentation/Verbal Skills, Quality Assurance Methodology, Regulatory Compliance, Requirements Management, Risk, Scripting (Scripting Languages), Software Development Lifecycle (SDLC), System Test, System Validation, Team Lead/Manager, Team Player, Test Scripts, Testing, Traceability, Validation Documentation, Validation Plan, Validation Testing, Writing Skills
LOCATION
Raritan, NJ
POSTED
30+ days ago
Job Description:
Job Summary:
  • CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
  • The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
  • Strong verbal and written communication skills
Experience:
  • Experience in the pharmaceutical, biotechnology, or medical device industry
  • 2+ years of experience with System Development Lifecycle (SDLC)
  • 3+ years of experience in Computer System Validation (CSV)
  • Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
  • Knowledge of FDA guidance and industry standards (e.g., GAMP)
  • Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously
  • Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports)
  • Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications
  • Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures

About the Company

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Katalyst Healthcares & Life Sciences