Hikma Pharmaceuticals USA Inc.

  • SR PROCESS ENGINEER

    Job Location US-OH-Bedford
    Posted Date 1 week ago(7/11/2018 5:44 PM)
    Job ID
    2018-4287
    Job Function
    Research and Development
  • Overview

    Responsible for all Process Development and Technology Transfer related tasks which are required for the efficient development of manufacturing processes for all new products.

    Support the pilot plant operations and personnel.

    Responsibilities

    • Partner with development scientists and the site technical services / manufacturing departments to ensure technical excellence from lab and pilot scale through commercialization of new and existing products.
    • Support pilot plant operations and personnel from planning, inventory control, documentation and execution of studies required for formulation and process development.
    • Act as Subject Matter Expert on at least one or several parenteral processes e.g. Freeze Drying, Emulsions, Suspensions, Liposomal formulations, aseptic manufacturing and terminal sterilization etc.
    • Plan, schedule, generate appropriate experimental design and execute Formulation and Freeze drying studies in the pilot plant.
    • Apply principles of Good Engineering and Pharmaceutical Practices as it relates to process development and technology transfer functions.
    • Generate appropriate experimental designs for scale-up and technology transfer.
    • Develop, review and approve protocols, reports, batch records, procedures, critical process parameter justifications, risk assessments, and project schedules for products as required.
    • Interface with site Technical Services, Engineering, Validation and Production to troubleshoot in support of product transfers.
    • Identify, evaluate and implement new technologies that will improve the quality and cost efficiency of parenteral manufacturing operations and processes.
    • Works to ensure proper safety and EHS policies are being followed by self and other scientists on the team. 

    Qualifications

    • 4 year degree in engineering, chemistry, or closely related field with demonstrated proficiency in experimental design, project management and validation.
    • Minimum of 5 years extensive pharmaceutical process engineering/development experience or advanced scientific degree plus 4 years of pharmaceutical process development experience.
    • Experience in aseptic product manufacturing, scale up, validation, and regulatory submissions are required.
    • Demonstrated knowledge of pharmaceutical formulation concepts, processes, scale-up, transfer, problem-solving, troubleshooting, and experimental design.
    • Demonstrated knowledge of pharmaceutical formulation concepts, processes, scale-up, transfer, problem-solving, troubleshooting, and experimental design.
      • Requires excellent communication, investigative and implementation skills.
      • Proficient in reading, writing, and speaking English.
      • Leadership potential.
      • Attention to detail.
      • Project Management.

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