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Senior CQV Engineer

Katalyst Healthcares & Life Sciences

  • Bloomington, IN
  • 5 days ago

    Highlights

    Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment. Requirements: Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.

    Numbers & Facts

    LocationBloomington, IN

    Description

    Roles & Responsibilities:
    • Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
    • Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
    • Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
    • Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
    • Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
    • Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
    • Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
    • Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
    • Support FAT, SAT, commissioning, and qualification activities as required.
    • Author, review, and revise CQV and engineering documentation, including:
    • User Requirements Specifications (URS)
    • Commissioning protocols
    • IQ/OQ/PQ protocols and reports
    • Risk assessments
    • Traceability documentation
    • Engineering studies
    • Deviations and discrepancy documentation
    • Turnover and closeout documentation
    • Ensure commissioning and qualification activities are appropriately documented and executed in accordance with project requirements, site procedures, and cGMP expectations.
    • Manage assigned engineering/CQV activities against project schedules and communicate risks, issues, and progress to project leadership.
    • Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
    • Support investigation and resolution of technical issues encountered during commissioning and qualification.
    Requirements:
    • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
    • Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
    • Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
    • Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
    • Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
    • Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
    • Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
    • Ability to author clear and technically accurate engineering and CQV documentation.
    • Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
    • Understanding of cGMP requirements and Good Documentation Practices.
    • Strong communication, organizational, and project coordination skills.
    • Ability to work independently while effectively collaborating within multidisciplinary project teams.
    • Onsite work requirement in Bloomington, IN.

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