Hikma Pharmaceuticals USA Inc.

  • EQUIPSTERILE OPER I

    Job Location US-NJ-Cherry Hill
    Posted Date 1 week ago(7/12/2018 3:18 PM)
    Job ID
    2018-4644
    Job Function
    Manufacturing
    Shift
    1st
  • Overview

    Position Located in Cherry Hil, NJ on 1st Shift

     

    Operator I position involves six (6) to twelve (12) months of supervised training in the preparation and sterilization of equipment and components used in the filling and compounding process. Training will start with equipment preparation duties and progress into responsibilities for the sterilization of processing equipment and components.  The training activities would be expected to progress in the following manner or until which time the incumbent has completed the required qualifications and has demonstrated the confidence and proficiency to conduct his or her work independently:

     

    Phase I – Demonstrate complete familiarity with the disassembly, cleaning, and preparation of factory equipment. Including but not limited to proper documentation and use of required cleaning equipment. Demonstrate ability to calculate waste bulk quantities and properly dispose of material.  Ongoing duties will then be assigned to include cleaning and preparation of equipment for sterile processing,

     

    Phase II – Demonstrate complete familiarity with the use of steam sterilizers, ovens and hot air drying ovens, including but not limited to proper documentation and ability to interpret chart readings and recorders. Once qualified, employee will be expected to load and run sterilization equipment in a sterile controlled environment.

     

    Phase III – At the discretion of Factory Management the position may also require that the incumbent complete training on product terminal sterilization.

     

    Upon successful completion of training program and applicable job qualifications, the incumbent must advance to the position of Equipment/Sterile Operator II.  In this capacity the employee will utilize the skills of equipment and sterile operations on a rotational basis with co-workers or as directed by area management.

    Responsibilities

    Tasks to be completed on a time regulated schedule:

    1. Ability to read filling schedule or filling request sheet to determine equipment/miscellaneous items to be prepared.
    2. Ability to read and follow applicable SOP’s, Job Aids, and Standard Set-up Sheets following training period.
    3. Preparation of miscellaneous items, tubing, and filters required by Filling or Compounding.
    4. Use of cleaning equipment including but not limited to jug washer, ultrasonic basins, WFI point of use panels, thermometers, pressure gauges, etc.
    5. Disassembly, cleaning and re-assembly of processing equipment.
    6. Demonstrated knowledge of proper documentation practices.(Sterile Operator Duties)

         (Sterile Operator Duties) 

    1. Movement and loading of carts/trucks from ovens and autoclaves to sterile storage areas.
    2. Successful completion of gowning qualification and aseptic training.
    3. Ability to understand and use operational procedures for steam autoclaves, depyrogenation and hot air ovens.
    4. Demonstrated knowledge and understanding of proper load configurations, parameter sheets, interpreting of pressure and temperature charts, and associated documentation.
    5. Performs/executes on-the-job training tasks as required when qualified.
    1. Adheres strictly to cGMPs and SOPs to ensure the quality and integrity of products.
    2. Performs all duties assigned to Equipment/Sterile Operator I.

    Performs all other duties as assigned by management personnel.

    Qualifications

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

    Language Skills :

    Candidate should have strong interpersonal skills and be an excellent communicator who can successfully interact and coordinate activities across departmental boundaries and at varying levels within the organization. Excellent English language comprehension, both written and verbal.

     

    Mathematical Skills :

    Ability to perform mathematical calculations associated with production documentation using whole numbers, common fractions and /or decimals.

     

    Reasoning Ability :

    Routine. Follows set guidelines or procedures.  Must be able to comprehend and follow all applicable SOPs.  Must be able to understand and interpret pressure and temperature charts and other associated process control documents.  Ability to work safely.

     

    Physical Demands :

    Must be able to lift between 25-50 lbs and pushing/pulling trucks weighing in excess of 50 lbs. Must be able to stand for long periods of time.

     

    Work Environment :

    Works in a controlled and aseptic area environment.   In aseptic areas employees must be totally gowned with mask, hood, coverall and gloves. At times environment can be confining.  The noise level is moderate to loud.  Use of hearing protection may be required.  Works with WFI (water for injection) at temperatures in excess of 50 degrees C.  Use of latex and /or protective gloves is required for most tasks. Must be gown qualified to work in a clean room environment.   

     

    Hazards :

    May incur minor cuts, abrasions, bruises, slight burns or muscle strains. Exposure to steam, high temperature equipment and water (WFI), and must work with pressure vessels (autoclaves).

     

    High School diploma or equivalent required

     

    No prior Equipment Prep experience is required; however preference would be given to candidates having prior equipment preparation, Clean Room, or sterile operator experience (including non site experience). Successful completion of applicable Job Aid qualifications and gowning training.

     

    Minimum of three [3] years of experience in a non GMP environment or a minimum of two [2] years of experience within a GMP manufacturing environment

     

     

     

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