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Elk Grove Village

    Validation Engineer - Elk Grove Village, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Elk Grove Village, United States

    2 days ago

    Default job background
    Description
    Responsibilities:
    • Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies.
    • Initiate an own 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 and adherence to ICH Q7.
    • Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
    • Lead discussions and provide guidance to personnel during risk assessments.
    • ssure adherence to Q9 "Quality Risk Management".
    • ssure Compliance with FDA and EU Regulations.
    • Evaluate, document, and develop investigations attributed to qualifications failures.
    • uthor Summary Reports, events, and applicable protocol amendments.
    • Execute and/or provide support during protocol executions.
    • ssure all the qualification items are tracked and successfully completed.
    • Perform GAP analysis and provide recommendations for existing qualifications.
    • bility to work in a fast pace, team-oriented environment.
    • Technical problem-solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
    • Potential to manage engineering projects from design through qualification, depending on candidates experience and skill set.
    • Candidate must adapt the work schedules to perform required qualification activities. This may require overnight and/or weekends.
    • Complies with all company policies and standards
    • Performs other functions as required or assigned
    Requirements:
    • BS or MS Degree in related Engineering field.
    • t Least 4 Years of experience in automated systems, project management is a plus.
    • t least 2 years' experience commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.
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