CSV Validation Engineer

Full Time, Contract: Independent, Corp-To-Corp, W2, Long Term


    CSV Validation

    Job Description

    Designation: Validation Engineer .
    Location: Tarrytown, NY(Hybrid from Day 1).
    Duration: Long Term.



    • Minimum of a Bachelor's degree in Computer Science, Information Systems, Business Administration, or an equivalent field required
    • Cloud Practitioner certification preferred

    Experience and Skills:


    • Minimum 4 years of relevant work experience
    • Experience in either Computer System Validation (CSV) activities and/or in Cloud computing supporting IAAS, PAAS & SAAS services
    • Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, and/or Validation Plans and Reports
    • Experience working with Jira, Jenkins, Github, Bitbucket, Artifactory, Chef or equivalent Agile Development tools


    • Detailed knowledge of GxP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, and Part 820
    • Experience in implementing regulatory requirements on Virtual Private Clouds (VPCx), Infrastructure as Code, and/or Containers services
    • Working knowledge of Global Regulations such as EU Annex 11, SOX, HCC, Security & Privacy, and/or ISO
    • Solid understanding and knowledge of DevSecOps, PMO, SDLC, GAMP 5, and/or ITIL frameworks
    • Knowledge of one or more of the following technologies and methodologies: Agile, CICD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI/ML, Intelligent Automation, Blockchain, Kubernetes, and/or SaMD
    • Industry experience within Pharmaceutical, Medical Device, and/or Biotech

    Key Responsibilities:

    • Ensure that all quality standards and global regulatory requirements are being met
    • Ensure that activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and using automation whenever feasible
    • Promote the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
    • Provide technical and procedural expertise/mentorship to the project teams as well as aligning with both internal and external collaborators
    • Plan, implement, and maintain the risk-based validation activities for GxP systems/applications
    • Support internal audits and Health Authority regulatory inspections for supported systems
    • Approve SDLC validation documentation including the approval to release system implementation and/or changes for production use, attend project team meetings, provide quality and compliance mentorship, support base business project activities
    • Work with globally diverse teams in an inclusive environment
    • Promote an environment which encourages the Company's Credo and the value of a diverse workforce