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    Associate III, Quality Engineering - Durham, United States - Biogen

    Biogen
    Biogen Durham, United States

    2 weeks ago

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    Description
    Job Description

    About the Role


    The Quality Engineering (QE) Associate III is responsible for overseeing key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.

    The QE Associate III will perform duties in line with site and corporate policies, cGMPs, safety, environmental, and human resources policies and procedures. They must be proficient in understanding the Biogen Quality Systems for coaching and continuous improvement across all Quality System functions.


    What You'll Do

    • Review and approve documentation related to facility, utility, equipment, analytical instruments, and automation lifecycle.
    • Review and approve changes impacting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, and business processes.
    • Provide cGMP guidance and quality risk management support for manufacturing issues, including equipment deviations and Corrective/Preventive Actions (CAPAs).
    • Support the site changeover program by overseeing equipment inspection, changeover documentation review, sampling, and equipment release.
    • Support site capital projects by offering GMP guidance, risk management input, and quality oversight.
    • Review and approve GMP Preventive/Corrective maintenance work.
    • Identify and resolve technical and compliance issues, implementing various Quality Systems improvements.

    Who you Are

    You are a motivated QA expert with expertise in Drug Manufacturing/Engineering and the ability to adapt to changing priorities. You are detail-oriented, a critical thinker, and can collaborate across different organizational levels. You value accountability and can ensure peers and stakeholders meet their commitments.

    Qualifications

    • Bachelor's Degree, preferably in Engineering, Life Sciences, or related Technical field.
    • 3-5 years of relevant industry experience.
    • Thorough understanding of FDA/EMA regulations, cGMPs, and ICH guidelines.
    • Strong oral and written communication skills.
    • Ability to multitask, coordinate activities, and resolve complex issues.
    • Demonstrated troubleshooting and problem-solving skills, with a focus on innovative solutions.

    Preferred Skills
    • Knowledge of cGMP Drug Substance or Drug Product Manufacturing.
    • Experience in Engineering, Validation, and Quality Systems development.

    Additional Information

    Why Biogen?

    Biogen is a global company dedicated to excellence and innovation. As a mid-sized biotech firm, we offer the stability of an established business while promoting an environment where individual contributions matter greatly. Our team consists of talented individuals with opportunities for growth and skill development. Together, we strive to deliver life-changing medicines, with each role playing a crucial part in our mission of Caring Deeply, Achieving Excellence, and Changing Lives.

    Biogen is committed to fostering a culture of inclusion and diversity, reflecting the communities we serve. We believe that varied backgrounds and perspectives enhance our innovation and strength as a company. Our focus is on building empowered and inspired teams where every individual feels valued and included. Visit our website to learn more about our diversity, equity, and inclusion initiatives.

    All qualified applicants will be considered for employment without discrimination based on various factors. Biogen is an E-Verify Employer in the U.S.

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