West-Ward Pharmaceuticals

  • Engineer II Validation

    Job Location US-OH-Columbus
    Posted Date 1 week ago(6/11/2018 7:21 AM)
    Job ID
    2018-4471
    Job Function
    Quality
    Shift
    1st
  • Overview

    Provides project leadership and guidance on validation/qualification initiatives to internal project teams and ensure project schedules are met. Ensures that West-Ward Pharmaceuticals systems, both computer and equipment, are in compliance with regulatory requirements through maintaining change control process and conducting periodic reviews.

    Responsibilities

    • Serves as project manager for validation/qualification aspects of moderately complex projects.
    • Author validation plans; Oversee development of: specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, and performance of both software and equipment. Provide direction on Equipment/Computer Change Control development. Facilitate assessment of computerized systems Electronic Record and Electronic Signature capabilities.
    • Ensures that the system’s validation state is maintained through proper testing as part of the change control program and re-validation as necessary. Performs a periodic review of systems to monitor the validation status of the system as well as an annual security audit. Executes validation role in validated system access process.
    • Participates in the development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates including test cases.
    • Trains colleagues on policies and procedures including the requirements for validation. Collaborate with higher level engineers on development of training materials.

    Qualifications

    • Bachelors degree in engineering or related scientific discipline required with a minimum of four (4) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting.

    • Require 1-3 years specific software or equipment validation experience in a pharmaceutical environment. Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience preferred.

    • Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports preferred.

    • Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, IDEA or RECORD preferred.

    WWHIGH

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