• Maintenance Specialist II

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(7/2/2019 3:04 PM)
    Job ID
    2019-1243
    # of Openings
    1
    Category
    Operations
  • Overview

    Provide maintenance of facilities, utilities and production assets in support of formulation, development and commercialization of innovative therapies at a GMP biopharmaceutical manufacturing plant.

    Responsibilities

    • Provide hands on preventative and corrective maintenance of mechanical, instrumentation and control (I&C) devices and systems
    • Troubleshoot and repair of motors, pumps, valves, instruments, control panel components utilized in HVAC, RODI, manufacturing machines, pH neutralization systems, compressed gases
    • Provide mechanical and I&C design and modifications on equipment for performance improvements
    • Provide vendor oversight on contracted maintenance and calibration activities. Includes scheduling, coordination, work scope identification, execution oversight, documentation generation and review
    • Support reliability engineering efforts on facility, utility and manufacturing equipment and assets
    • Computerized Maintenance Management System (CMMS) administration for all asset maintenance life cycle requirements, including asset registration, maintenance plan and schedule development, work order generation and closure
    • Maintain equipment and system documentation, including drawings, specifications, certifications, data sheets, bill of materials, spare parts lists, operating manuals and turn over packages
    • Provide maintenance subject matter expertise in support of quality manufacturing and disposition investigations. Assist on development and implementation of corrective and preventative actions (CAPA)
    • Participate on regulatory inspection readiness preparations and support audits as required
    • Aide engineering design and specification of new or changes to facility, utility and manufacturing equipment, assets and systems
    • Comply to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)
    • Aide in the creation and revision of SOP’s
    • Provide off-shift, On-Call support for facility emergencies

    Qualifications

    • Maintenance or technician accreditation
    • Minimum of 3 years’ experience in equipment maintenance
    • Experience in a Good Manufacturing Practice (GMP) manufacturing facility
    • Proficient in Microsoft applications
    • Experience working in a Computerized Maintenance Management System (CMMS)
    • Proven team collaboration experience
    • Position requires the ability to work with mechanical equipment and lift up to 50 lbs
    • Position requires working with chemicals
    • Must be able to work in both cleanroom and chemical laboratory environments

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