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Scientific. Clinical. Software Engineering

Validation Engineer -Entry Level

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -062019-25025 Region: Edison-New Brunswick Metro Area

Job Description

  • Bachelor s degree in Engineering or a related field from an accredited college or university 1 year of engineering validation experience, preferably in a pharmaceutical environment
  • Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
    Assures that protocols are approved through proper channels; writes and revises validation protocols.
    Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
    Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization.
    Assures that all test data is gathered and recorded in accordance with cGMP requirements.
    Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
    Writes final reports and assures that they are approved through proper channels.
    Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas.
    Develops and communicates project timelines and status.
    Complies with all GMP and safety requirements, SOP s and Company policies and procedures.
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