• XPJ(中国区)官方网站

     

    Computerized Systems Validation (CSV) Engineer

    REQ-10045596
    3月 28, 2025
    Netherlands

    摘要

    We are seeking a : Computerized Systems Validation (CSV) Engineer

    About the Role

    Key Responsibilities:

    • Owning the computerized system validation site masterplan.
    • authoring user requirements, validation plans, protocols, reports and risk
    • Assessments regarding computerized systems.
    • Execute the required tests in collaboration with Production department, QC
    • department or external suppliers where applicable
    • Perform periodic reviews on existing validated systems to ensure systems are in a validated stat during the complete life cycle.
    • Supports audits
    • Authors and updates SOPs, WIs when required
    • Participate in design checks and reviews to guarantee the required quality.
    • Being a thought partner for Capital Investments, equipment validation and process engineering
    • Develop partnership with Global Novartis Engineering teams ensuring consistence and standardization of Engineering process.
    • Lead or participate on the assessment or implementation of special projects or initiatives with cross-functional teams.

    Essential Requirements:

    • Degree in Engineering, Medical/Pharmaceutical sciences, Biotechnology (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent.
    • Minimum 3 years of working experience within (pharmaceutical) GMP and or isotope manufacturing.
    • Good understanding of related guidelines GAMP 5 (ISPE), USFDA 21 CFR Part 11 en Eudralex Annex 11
    • Good command of Dutch and English language, both written and speaking.
    • Attention to safety, able to work in an organized and structured manner through protocols and standards
    • Attention to detail, ability to look at the process through the eye of the end-user as well as an engineer
    • Project management skills with the ability to handle multiple projects at one time
    • Basic IT skills
    • Analysis capability and reporting skills

    Commitment To Diversity And Inclusion

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

    Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

    Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

    Operations
    Innovative Medicines
    Netherlands
    Baarle Nassau
    Technical Operations
    Full time
    Temporary (Fixed Term)
    No

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

    A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
    REQ-10045596

    Computerized Systems Validation (CSV) Engineer

    Apply to Job

    Source URL: http://apricot2002.net/careers/career-search/job/details/req-10045596-computerized-systems-validation-csv-engineer

    List of links present in page
    1. http://www.novartis.com/about/strategy/people-and-culture
    2. http://talentnetwork.novartis.com/network
    3. http://www.novartis.com/careers/benefits-rewards
    4. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Baarle-Nassau/Computerized-Systems-Validation--CSV--Engineer_REQ-10045596-1
    5. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Baarle-Nassau/Computerized-Systems-Validation--CSV--Engineer_REQ-10045596-1