WuXi AppTec

  • Senior Process Engineer

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3767
  • Overview

    Specifies, delivers, and supports key process equipment, which increases the capability and capacity of WuXi AppTec Manufacturing and Testing Operations in cell and gene therapies. Lead and manage new process equipment introduction and cost effective process improvements. Applies process engineering principles and GMP knowledge in single use process equipment for sterile drug manufacturing for all aspects of project delivery from feasibility through manufacturing/laboratory start up and hand over to the end users. The position will continue to support usage and monitoring of equipment following hand over and during necessary maintenance activities. Aligns the requirements of other functional groups such as EHS, QA, Manufacturing, Testing, Facilities/ Metrology for project delivery. Directly responsible for tracking cost, schedule, targets and achievements.

    Responsibilities

      • Manage multiple single-use process equipment projects from conceptual through detailed design, commissioning and qualification, and process development, for a cell and gene therapies manufacturing facilities.
      • Manage outside engineering consultants, and equipment vendors.
      • Applies sound engineering and project management principles in the procedural delivery of said project.
      • Support end users to define process equipment User Requirements, and establish Design Basis.
      • Interface with client representatives and other functional groups such as EHS, QA, Manufacturing, Testing, Facilities/Metrology, etc. to manage and coordinate the development of design deliverables.
      • Issue Request for Proposals (RFP) to equipment vendors. Specify equipment performance and design requirements.  Perform technical and commercial evaluations and recommend a vendor.
      • Review and approve design documentation including engineering calculations, specification and drawings for process equipment/systems.
      • Manage process equipment/system commissioning and qualification.
      • Review and approve commissioning and qualification protocols.
      • Provide qualification and troubleshooting support for equipment and systems.
      • Independently manage technical, engineering and code compliance matter on the project delivery, making decision on engineering problems and methods.
      • Support equipment troubleshooting.
      • Develop innovative solutions to manufacturing/laboratory processes.
      • Monitor equipment for reliability.
      • Review process equipment specifications, Process Flow Diagrams and P&IDs for the Philadelphia site.
      • Execute capital projects as a Project Engineer as necessary
      • Provides engineering support  to other department
      • Generates protocols and procedures
      • Ability to manage projects within a GMP environment
      • Ability to work in a team environment and independently as required
      • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
      • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices

    Qualifications

     

    Experience / Education   

    • A minimum of 10 years of relevant experience or equivalent
    • Working knowledge of GMP requirements
    • Bachelors’ degree in Chemical Engineering, or Mechanical Engineering, or equivalent. Masters’ and PE preferred or equivalent experience

     

    Knowledge / Skills / Abilities:

     

    • Proficient in Oral & Written communication skills
    • Must be able to read, write and understand English.
    • Proficient in Microsoft Excel and Projects.

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled 

     

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