• Senior Manufacturing Engineer

    Posting Date 6 months ago(5/7/2018 11:28 AM)
    Requisition ID
    Job Location(s)
    West Lafayette IN United States
    Position Type
    Full Time
    Cook Biotech Inc.
  • Overview

    Cook Biotech is seeking a process-minded individual with experience in Pharmaceutical or Medical device manufacturing. The position has responsibility for process validation and process quality activities. A desire to provide leadership and mentor young engineers is preferred. 


    • Seek out, lead, develop and implement advanced manufacturing solutions as agreed-upon by key stakeholders.
    • Conduct process validations and re-validations in a timely manner and according to quality system requirements
    • Ensure process validations for Core Products are consistently relevant, appropriately implemented and documented.
    • Select, qualify and improve production equipment, tools and instruments with the goal of preventing defects, designing for manufacturability and improving quality.
    • Demonstrate and teach effective use of continuous improvement tools (e.g.5S, value streatm mapping, theory of constraints, kaizen) to CBI teams.

    • Relentlessly eliminate waste from processes by evolving the CBI quality system.

    • Conduct risk analyses and sustaining engineering activities for Core Products as-needed to support Regulatory or other quality sustem activities.
    • Write specifications and instructions.
    • Coordinate and/or provide training on process improvements to production personnel.

    • Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties.


    • Bachelor's degree in Engineering
    • At least five (5) years previous experience in engineering and a manufacturing environment, pharmaceutical or medical device preferred
    • Able to work independently and in interdepartmental teams
    • Good project management skills and able to work on multiple projects  simultaneously
    • Able to effectively listen to ideas and concerns coming from Production personnel

    • Able to effectively communicate ideas to others
    • Good record keeping and documentation skills
    • Willing to work with material derived from animal tissues
    • Sufficient background to generally understand medical and biotechnology terminology.
    • Ability to make prototypes and conduct bench tests


    Physical Requirements:

    • Must be able to perform the essential functions of the job, with or without reasonable accommodations
    • Limited exposure to hazardous chemicals used in the manufacture of the product

    • Physical demands are typical of an office and classroom environment.


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