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    Validation Engineer - North Chicago, United States - Sterling Engineering Inc.

    Sterling Engineering Inc.
    Sterling Engineering Inc. North Chicago, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Job Overview:

    The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes.

    Responsibilities:

    • Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols, as well as Validation/Qualification Policies.
    • Initiate Change Controls - provide validation assessments and remediation plans as required by the system/equipment/components.
    • Develop Commissioning and Qualification Plans.
    • Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211, as well as adherence to ICH Q7.
    • Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
    • Assure Compliance with FDA and EU Regulations.
    • Evaluate, document, and develop investigations attributed to qualifications failures.
    • Author Summary Reports, events, and applicable protocol amendments.
    • Execute and/or provide support during protocol executions.
    • Assure all the qualification items are tracked and successfully completed.
    • Perform GAP analysis and provide recommendations for existing qualifications.
    • Validation/Qualification activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.)

    Preferred/Required Education/Skills:

    • Bachelor's or Master's degree in Engineering, Science, or a related field.
    • 3+ years of experience with commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies. Temperature mapping is a plus
    • Pharmaceutical, healthcare, or medical device industry experience is a plus

    Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

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