Hikma Pharmaceuticals USA Inc.

  • VALIDATION ENGINEER

    Job Location US-NJ-Cherry Hill
    Posted Date 1 month ago(6/7/2018 12:01 PM)
    Job ID
    2018-4578
    Job Function
    Quality
    Shift
    1st
  • Overview

    This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment.  Validation activities include research, protocol writing/execution and final report generation.  Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented.  Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

    Responsibilities

    1. Takes lead role on new equipment validation. Writes protocols, reports (GTRs), Site and Master Batch Record Change Controls and Executes protocols that involves coordination with many functional areas including Production, Planning, Testing Laboratories, etc.
    2. Applies cGXPs knowledge, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
    3. Performs a variety of projects/studies in areas that include Equipment Validation, as well as projects/studies to support Manufacturing Operations.
    4. Serves as project lead with projects of extended scope and cross-functional teams.Works closely with facilities engineering for equipment implementation, installation, and commissioning.
    5. Mentors and provides leadership to junior team members.

    Qualifications

    BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) having a minimum of 4+ years related experience or 3+ years related experience w/ an advanced degree or demonstrated performance within a technical department within the organization.

     

    1. Ability to communicate effectively at all levels in verbal and written form.
    2. Direct or indirect industry knowledge and the ability to learn new technical information and concepts.
    3. Ability to work independently or in teams.
    4. Ability to walk some distance 1-3 miles, stand for 3-6 hours and periodically lift 10 - 40 lbs during the course of a work day as required.
    5. Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require.

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