Production Engineer

Summary of Responsibilities

The Production Engineer reports to the Production Manager and will be the point person for calibration, maintenance and repair of Production Systems and Equipment. The Production Engineer will lead and oversee manual and semi-automatic manufacturing processes to support production operations. The Production Engineer will be responsible for writing and executing Equipment, Process, and Product Validations. The Production Engineer will lead the completion of process development/process characterization, new product commercialization or other related projects.

Essential Duties and Responsibilities

To meet the standards of this position, personnel must be able to perform each essential duty with proficiency.

  • Complete maintenance and calibrations tasks for manufacturing equipment.
  • Develop, lead, and execute equipment and process validations (including the design of specifications, IQ, OQ, and PQ). Author validation summaries, reports and complete risk assessments.
  • Execute various manufacturing processes (involving precise measurement, step-by-step instructions, packaging, and quality control testing) for products used for internal Clinical Lab Developed Tests and external IVD products.
  • Ensure adherence to standard operating procedures, work instructions, current Good Manufacturing Practices (cGMP), safety policies and procedures.
  • Document manufacturing and testing with adequate details in reports and batch records using Good Documentation Practices (GDP).
  • Facilitate the transfer of new products from Research and Development to the Production Department.
  • Revise work instructions, specifications, and SOPs within document control using change control.
  • Interface with external vendors (calibration providers, material suppliers, equipment suppliers).
  • Other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • Strong computer skills (competency with Microsoft Office, Statistical Analysis)
  • Exceptional problem-solving abilities
  • Ability to work both as part of a team or individually/independently
  • 2 plus years of experience working in regulated manufacturing environment
  • Basic statistics knowledge, including data analysis and hypothesis testing

Education and Experience

Minimum Education and Related Experience:

  • Bachelor’s Degree in Biomedical, Chemical or Mechanical Engineering or related field.

Apply today for the Production Engineer position at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to careers@miravistalabs.com if you have any problems with the web form).

MiraVista was founded in 2002 by Dr. Lawrence Joseph Wheat, whose groundbreaking research resulted in the development of the first histoplasmosis antigen test. Today, MiraVista serves the medical and healthcare sectors in the U.S. and Canada by processing over 100,000 tests per year for fungal infections and continuing both clinical research and test development. These include antigen and antibody detection tests for diagnosing coccidioidomycosis (valley fever fungus), aspergillosis, histoplasmosis, blastomycosis and cryptococcosis. MiraVista’s team of experienced infectious disease specialists and scientists have collectively published more than 1,000 scientific research articles.

MiraVista Diagnostics is an Equal Opportunity Employer.

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