• Maintenance Technician

    Posting Date 1 month ago(4/13/2018 11:58 AM)
    Requisition ID
    2018-4284
    Job Location(s)
    Indianapolis IN United States
    Travel
    None
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Regentec LLC
    Category
    Production/MFG/Operations
  • Overview

    The Maintenance Technician is a part of the Operations Support Team at Cook Regentec. The primary focus of the job is to approve and oversee instrument calibration, equipment maintenance and validation to meet GMP and other compliance requirements. This position works cross-functionally with development and manufacturing. Additional efforts in continuous improvement of the function is also an expectation. 

    Responsibilities

    • Monitor and maintain calibration instruments and equipment
    • Ensure all calibrations are performed in a timely manner
    • Follows standard calibration procedures per Standard Operating Procedures (SOP’s)
    • Provides input into the review and revisions of SOPs
    • Documents all work in controlled documents in accordance with SOPs
    • Performs all work in accordance with company policies and procedures
    • Initiates purchase requisitions to order new or replacement equipment
    • Work with engineers, vendors and internal teams
    • Assist with audits, both internal and external
    • Work within computer maintenance system
    • Coordination and communication with other functional teams
    • Ability to work independently or in a team setting
    • Ability to troubleshoot and make appropriate decisions in a complicated work environment

    • Manufacturing Support:  Responsible for maintaining all manufacturing process equipment by performing preventative maintenance, routine repairs and calibration with minimal down time.  Installation, modification, set up and/or qualification of any new or relocated equipment 
    • Available for on-call emergencies
    • Ensure safety policies are adhered to
    • Create or update preventative maintenance procedures and generate written reports assigned
    • Assists with facilities projects as required, preventative maintenance, janitorial, trouble shooting, repair, calibration & documentation of Production and facility support equipment per guidelines, procedures and timelines 
    • Work with Production, QA, & Engineering on projects as required.  Builds and/or performs duties associated with the job

    Qualifications

    • Minimum High School Diploma
    • Associates degree is a plus
    • Ability to read P&IDs
    • Able to perform mathematical calculations
    • Ability to work in various computer programs.Minimum of one to three years of related experience in calibration is required
    • Minimum of one to three years of experience in a cGMP manufacturing environment required
    • Prior experience in the pharmaceutical, biotechnology or medical device industry preferred

     

    Physical Requirements:

    • Frequently required to walk, climb, balance, stoop, bend, kneel, crouch or crawl, and talk, hear, and smell

    • Constantly required to stand/or sit, squat, turn/twist, reach, use hands to: finger, handle, feel or operate objects, tools or controls, and computer keyboards
    • Occasionally lift, carry, push or pull up to 50 pounds and/or frequently lift, carry, push or pull up to 20 pounds
    • Conducts most fault recovery activities and tracking

    • Able to work in clean room environments
    • Able to work in office space
    • Strong interpersonal skills
    • Executes troubleshooting, maintaining, inspecting, modifying, and repair of the systems
    • Act as member of team to deliver results and reacts to issues
    • Performs all running maintenance and operating PM’s
    • Performs diagnostic evaluations and corrective actions on equipment malfunctions

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