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    Process Engineer - Raleigh, United States - Katalyst Healthcares and Life Sciences

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    Description

    Responsibilities:

    Installation and startup testing of new equipment (generation, execution, and close out of engineering test plans) Ownership of system P&IDs - responsible for engineering review, walk-downs, redlines & system changes.

    Generation, review, and approval of engineering lifecycle documentation for assigned systems. Review, approval, and execution support of C&Q protocols for assigned systems. Generation, review, and approval of engineering change management for assigned systems. New systems troubleshooting floor support.

    This individual will work closely with Equipment SMEs, MS&T, and equipment End Users to investigate and troubleshoot issues related to process equipment.

    Provide direct engineering support and Subject Matter Expertise for process equipment such as:
    (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...). This includes serving as the Engineering owner for process equipment. Skills required to meet expectations of the role include high-quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. Provide daily, on-the-floor support to manufacturing. Facilitate tech transfer, process fit, and facility fit for new projects. Support the team goal of achieving gold standard batches and right the first-time processing. Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls. Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.


    Requirements:
    4-6 Years experience in a GMP manufacturing/engineering environment and a B.E. / B.S. degree in Chemical Engineering. Must have experience in installing and executing new equipment.

    Must have previous Biotech or Biopharmaceutical industry experience working in a process engineering role Must have strong knowledge and experience supporting cleaning (CIP, COP, glass washers, detergent distribution), sterilization (SIP, autoclaves), bench-top analytics (Cedex, Nova, filter integrity testers) and single-use systems.

    Good report and technical writing skills with the ability to drive changes in a cross-functional team environment Experience with all aspects of biotech and pharmaceutical industries.


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