WuXi AppTec

  • Validation Specialist

    Job Locations US-MN-St. Paul
    Job ID
    2018-4637
  • Overview

    Lead commissioning and validation activities in support of testing and manufacturing operations in compliance with applicable regulations and standards. Support continuous improvement initiatives and projects.

    Responsibilities

    • Support the Equipment and Validation Programs (Saint Paul)
    • Lead Qualification and Validation activities including:
      1. Facilities, equipment, instruments, and systems
      2. Develop validation plans, protocols, and testing specifications
      3. Analyze validation data and prepare reports and supporting materials
    • Support implementation of capital projects
    • Support continuous improvement initiatives in the Equipment and Validation Programs
    • Working knowledge of cGXP, ICH, USP, ISO and other regulatory requirements and guidelines
    • Experience across a broad range of qualification and validation disciplines
    • Project management experience preferred
    • Process and method development experience preferred
    • Technology transfer experience preferred

    Qualifications

    Experience / Education   

    • Minimum of 2 years’ experience
    • Minimum of a Bachelor’s Degree in a Scientific or Engineering discipline
    • Computerized System Validation experience preferred

     

    Knowledge / Skills / Abilities:

    • Scientific and Technical proficiency
    • Critical thinking and problem solving skills
    • Ability to work on multiple projects of varying scope
    • Ability to work with a customer focus mindset (internal and external)
    • Ability to work independently with minimal supervision
    • Ability to effectively contribute to team based projects
    • Proficient in Oral & Written communication skills
    • Ability to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

     

    Physical Requirements:

    • Must be able to work in an office environment with minimal noise conditions
    • Must be able to wear appropriate PPE
    • Must be able to work in environment with variable noise levels
    • Ability to sit for long periods of time

     

    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

     

    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

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