• Technical Writer and Validation Specialist

    Posting Date 7 months ago(6/27/2018 8:46 AM)
    Requisition ID
    Job Location(s)
    Indianapolis IN United States
    Less than 10%
    Shift Type
    Position Type
    Full Time
    Cook Regentec LLC
    Information Technology
  • Overview

    The primary function of the Technical Writer / Software Validation Specialist will be maintaining lifecycle management of various commissioning, qualification, and/or validation facets within our Biotechnology, Medical Device, and Pharmaceutical sites.  This will include the need to develop, implement, and execute tests based on standards, user requirements, end user scenarios and design specifications to ensure the highest level of quality possible for a software release.


    • Computer System Validation (CSV)

    • Responsible for Software Compliance with FDA CFR Part 11 for Electronic Records and Signatures

    • Responsible for Software Compliance with Annex 11, The Rules for Governing Medicinal Products in the European Union

    • Responsible for Software Compliance with FDA Guidelines, USP, GAMP 5, GMP, ISO, etc.
    • Project Validation and/or Master Validation Planning.

    • Design and deliver end user and internal documentation for software products, including User Guides, Installation Guides, Release Notes, Online Help, and other documentation as required.

    • Develop test plans for small/medium/large size projects including embedded systems and applications

    • Design and execute manual test cases based on standards, user requirements, end-user scenarios and design specifications

    • Accurately update and complete documentation on test results and analysis
    • Proactively identify issues, troubleshoot issues, and escalate concerns as appropriate

    • Triage test failures and problems. Provide clear and concise defect reports to the responsible individuals in a timely manner

    • Execute and implement appropriate Risk management

    • Adhere to strict procedural, regulatory, and quality standards including thorough and accurate documentation and testing protocols.

    • Participate in project planning and design discussions as a member of a cross-functional team

    • Work with peers to achieve project, personal and team goals

    • Maintain and enhance job-related skills by self-teaching or participating in appropriate training and development programs

    • Responsible for audits/inspections of validation exercises

    • Support Quality documentation of Validation and IT process in Quality Document Management System

    • Manage document libraries, ensuring files are organized, easily accessible, and archived when appropriate


    • Bachelor’s Degree in Computer Science, Electrical Engineering, Engineering Technology, or equivalent
    • Minimum of two (2) years validation/testing experience
    • Familiarity with Quality Systems Regulations (e.g. FDA CFR21 PART 11, ANNEX 11, GAMP 5, ISO 13485, ISO 9001) a plus
    • Knowledge of CSV

    • Excellent Documentation Skills
    • Excellent Communication Skills
    • Experience with Problem and Risk Analysis and Resolution a plus


    Physical Requirements:

    • General office environment
    • Must be able to sit for long periods of time
    • 10% travel


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