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    Process Engineer - Lee, United States - BERKSHIRE STERILE MANUFACTURING LLC

    BERKSHIRE STERILE MANUFACTURING LLC
    BERKSHIRE STERILE MANUFACTURING LLC Lee, United States

    5 days ago

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    Description

    Job Description

    Job Description

    Position Summary

    The Process Engineer will lead tech transfer projects from client or small scale to manufacturing/large scale in a manner that meets safety, quality, and operational performance expectations. The key function of this role will be to deliver effective, safe and efficient manufacturing processes for parenteral drug products.

    Duties and Responsibilities

    • Layout manufacturing process flow for parenteral drug products based on tech transfer information
    • Identify and order materials required to perform development and manufacturing
    • Identify tooling and equipment required to perform development and manufacturing
    • Develop and execute study protocols to evaluate manufacturing processes and write associated reports
    • Develop and execute batch records defining bill of materials and manufacturing processes
    • Develop SOPs for equipment operations
    • Design and execute performance qualification of instruments
    • Identify technical issues and provide necessary solutions to determine root cause
    • Work with operations, engineering, QA, maintenance, suppliers and management to resolve problems
    • Accurately document and record necessary data and reports with appropriate conclusions
    • Complete quality events such as deviation with sound judgement and scientific principal
    • Provide feedback on process improvement initiatives to improve operating performance
    • Maintain knowledge of equipment and manufacturing technology changes and core process technologies
    • Source equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance, and other personnel
    • Other duties as assigned

    Regulatory Responsibilities

    • N/A

    Supervisory Responsibilities

    • N/A

    Experience

    • One (1) to three (3) years in a pharmaceutical environment

    Education

    • Process Engineer: Bachelor's degree in Chemical Engineering, Chemistry, Biology, or Pharmaceutical Science

    Knowledge, Skills & Abilities

    • Solid working knowledge in the application of engineering principles, scientific analysis
    • Able to perform routine and complex work instructions under limited supervision
    • Able to perform routine problem solving referring complex problems to supervisor
    • Calculation, data analysis, statistics and applied mathematics
    • Project management
    • Mechanical aptitude
    • Microsoft Office, Visio or other related software
    • Excellent writing skills
    • Attention to detail
    • Oral communication skills

    Physical Requirements

    • Ability to meet gowning requirements
    • Ability to remain stationary for prolonged periods of time
    • Able to periodically lift up to 50lbs
    • Satisfactory audio-visual acuity
    • Gross and fine motor skills to manipulate instruments
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