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Equipment Engineer
Equipment EngineerKatalyst CRO • Boston, MA, United States
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Equipment Engineer

Equipment Engineer

Katalyst CRO • Boston, MA, United States
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  • Authoring and reviewing of SOP's (both new and existing).
  • Authoring and reviewing Equipment Requirements Specifications.
  • Document calibration and maintenance requirements, generate procedures.
  • Supporting Equipment Management Program.
  • Schedule and work with suppliers to perform service, installation, calibration, maintenance activities for facility, utilities, and equipment.
  • Troubleshoot manufacturing issues to identify root cause and implement corrective actions.
  • Initiate and execute Equipment Impact Assessments on failures.
  • Collaborate with cross-functional teams to drive continuous improvement efforts.
  • Communicates technical information within the team.
  • Primarily hands-on workers.
  • Authoring and supporting efforts on any on the Job Training.
  • Execute Equipment Qualification Protocols.
  • Perform investigations and support CAPAs as needed.
  • Ensure proper documentation is completed to meet quality system requirements.
  • Ensure compliance with all applicable regulations and standards.
  • The employee may be required to perform other duties as assigned by management.

Responsibilities

  • Authoring and reviewing of SOP's (both new and existing).
  • Authoring and reviewing Equipment Requirements Specifications.
  • Document calibration and maintenance requirements, generate procedures.
  • Supporting Equipment Management Program.
  • Schedule and work with suppliers to perform service, installation, calibration, maintenance activities for facility, utilities, and equipment.
  • Troubleshoot manufacturing issues to identify root cause and implement corrective actions.
  • Initiate and execute Equipment Impact Assessments on failures.
  • Collaborate with cross-functional teams to drive continuous improvement efforts.
  • Communicates technical information within the team.
  • Primarily hands-on workers.
  • Authoring and supporting efforts on any on the Job Training.
  • Execute Equipment Qualification Protocols.
  • Perform investigations and support CAPAs as needed.
  • Ensure proper documentation is completed to meet quality system requirements.
  • Ensure compliance with all applicable regulations and standards.
  • The employee may be required to perform other duties as assigned by management.

    • Requirements :

  • A minimum of bachelor's degree in engineering or Technical field
  • 3+ years of prior experience with calibrations and maintenance activities preferred.
  • Regulated industry experience, medical device or pharmaceutical experience preferred.
  • Strong technical aptitude and problem-solving skills.
  • Ability to work independently and as part of a team.
  • Attention to detail and ability to maintain accurate records.
  • Machine shop experience preferred.
  • Communicate effectively with cross-functional teams.

    • Seniority level

    Seniority level

    Associate

    Employment type

    Employment type

    Contract

    Job function

    Industries

    Pharmaceutical Manufacturing

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