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    Commissioning Qualification Engineer - San Francisco, United States - HYDE ENGINEERING + CONSULTING

    HYDE ENGINEERING + CONSULTING
    HYDE ENGINEERING + CONSULTING San Francisco, United States

    3 weeks ago

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    Description

    The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, including media preparation, harvest capture and clarification, buffer preparation, clean-in-place systems, and manufacturing support equipment. This engineer will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT) and Commissioning and Qualification (C&Q).

    Responsibilities

    • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
    • Perform systems and P&ID Walkdowns, commission equipment, and provide Equipment Turnover Packages (ETOPs)
    • Spray coverage testing, cleaning verification swabbing, and sample submission practices
    • Provide process engineering support for clean water systems, CIP, SIP and pharmaceutical process equipment
    • Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports
    • Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget.
    • Promote cGMP and regulatory compliance into assigned projects
    • Review and modification of standard operating procedures (SOPs) for various equipment
    • Document, monitor, and report on project deliverables
    • Manage project documentation such as protocols, reports, calibration certificates, and process trends.

    Desired Skills And Experience

    • BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
    • Understanding of a variety of equipment including: process vessels, chromatography skid/column, UF/DF skid, centrifuge, CIP, buffer preparation, glass washers and parts washers
    • Ability to work on complex or undefined problems and quickly identify and address critical issues
    • Ability to create an environment of trust, compliance, continuous improvement and learning
    • Demonstrated ability to manage multiple priorities with aggressive timelines
    • Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately
    • Ability to relate with people at all levels within an organization, including diverse cultures
    • Willingness to travel within the United States as needed

    Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website:

    You will find the following values reflected in our company:
    • Family
    • Integrity
    • Respect
    • Wisdom
    • Adventure

    Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.

    Associate

    #hydrid
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