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Process Engineer I- Salt Lake City, UT

Teva Pharmaceuticals Salt Lake City, UT Engineering

Under general supervision, provides support in formulation and development of Transdermal products.
Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities.
Involves developing manufacturing processes for pharmaceutical products, creating and updating procedures and specifications, writing reports on documentation studies performed and results obtained.
Involved in new product formulation, scale-up process optimization, process validation and technology transfers.
Responsible for the design and development of products and processes used in manufacturing from small-scale manufacturing to commercial operation.
Responsibilities

  • Independently works with formulation group to develop and optimize manufacturing process.
  • Independently designs and performs experiments in the development of processing unit operations
  • Oversees and coordinates development manufacturing events.
  • Writes and executes development protocols for all processing unit operations.
  • Maintains current and accurate documentation for raw materials and process specifications such as Standard Operating Procedures (SOP), Material Specifications (MS), Master Production Formula (MPF), etc.
  • Prepares assigned sections of IND and NDA FDA submissions. Assist with responding to FDA questions related to submissions.
  • Interfaces with other departments and outside vendors to source, procure and write specifications for raw materials and final products.
  • Conducts presentations of data and findings to management as required.
  • Performs related duties as assigned.
  • Assist with SAP data migration and validation related duties
    Qualifications

    Bachelor’s degree in engineering or a related field from an accredited college or university. Minimum of two (2) – four (4) years of process engineering experience, preferably in pharmaceutical, food, or cosmetic manufacturing environment, or an equivalent combination of training and experience. SAP data migration experience is strongly preferred. Basic knowledge of Chemistry and Quality by Design (QbD) principles, such as risk assessment and statistical design of experimentation is preferred.
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