• Jt614 - Validation Specialist

    Quality Consulting Group (Villalba, PR)


    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

    Responsibilities:

    + Evaluate the impact of validated computerized systems on existing work instructions and processes.

    + Prepare and execute computer system validation protocols and generate comprehensive reports.

    + Develop and maintain Installation Qualification (IQ) documentation.

    + Collaborate with process owners to implement changes to work instructions and ensure compliance.

    + Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed.

    + Ensure adherence to company procedures, quality system regulations, and industry standards.

    + Apply technical expertise and knowledge of engineering practices to optimize equipment and manufacturing techniques.

    + Organize and track project progress, maintaining detailed documentation and status updates.

    + Contribute to cross-functional projects and support milestone completion.

    + Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making.

    Qualifications:

    + Bachelor’s degree in Engineering

    + Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience

    + Practical knowledge and demonstrated competence in validation and quality systems

    + Investigation and root cause analysis skills

    + Technical writing knowledge

    + Organization and Communication skills

    + Process Validation and Computer software validation knowledge

    + Experience in SDLC

    + Experience in medical devices or other highly regulated industry (e.g., medical devices, pharmaceuticals, biotech)

    + Excellent verbal and written communication skills in both English and Spanish

    + Availability to work 1st shift

     

    Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

     

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