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Validation Engineer

Eurofins USA BioPharma Services

Validation Engineer

San Diego, CA
Full Time
Paid
  • Responsibilities

    Job Description

    • Applies GMP/GLP in all areas of responsibility, as appropriate
    • Demonstrates and promotes the company vision
    • Regular attendance and punctuality
    • Compliance - Stay current with client, regulatory, validation, IT, and e-record compliance regulations, and requirements. Ensure projects are completed in compliance with existing quality systems. Provide support to implement new quality systems and programs.
    • Research - Assist with research of instrumentation with information obtained from vendors, manuals, and other resources to introduce duplicate/similar instruments and software. Assist with integration of instrumentation into existing data center environments and workflows.
    • Technical Writing - Author validation deliverables in accordance with established validation program. Assist with developing/enhancing instrumentation procedures.  Training - Provide guidance and coaching within a team environment. Provide training to technical groups.
    • Validation Support - Accurately update validation program components and maintain LIMS instrument database entries. Perform periodic review for chambers and compile and assist with periodic review of computerized systems. Generate monitoring, trending, and departmental reports. Perform routine project close out activities.
    • Validation Testing - Assist with determining the approach to validate instrumentation. Utilize risk - based rationale to support approach. Provide quality project oversight and guidance to assist technical with testing and ensure documentation is complete and reviewed. Summarize results and maintain documentation in an organized GXP compliant manner to demonstrate status.
    • Conducts all activities in a safe and efficient manner
    • Performs other duties as assigned
  • Qualifications

    Qualifications

    • Bachelor's degree in chemistry, microbiology, biology, engineering, computer science, or other related degree concentration
    • One year of previous expereince as a system administrator or providing technical support for laboratory software applications 
    • One year of technical writing including investigations, procedures, training, and/or validation documents
    • Authorization to work in the United States indefinitely without restriction or sponsorship

    Additional Information

    Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.

    • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
    • Life and disability insurance
    • 401(k) with company match
    • Paid vacation and holidays

    EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.