Process Engineer (Biopharmaceutical Industry)

Company: Mentor Technical Group
Location: College Station
Posted on: May 27, 2023

Job Description:

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:

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  Develop and maintain equipment and unit operation standards and procedures utilizing the 4M (Man, Materials, Machinery, and Methods) approach including:
  
  
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  Support new equipment purchasing, URS creation and or revision, equipment qualification and procedure creation and or revision.
  
  
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  Creation and or revision of recipes or methods for various platforms.
  
  
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  Review and/or Approve equipment qualification limits.
  
  
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  Review Calibration Tolerances and Approve Out of Tolerance Investigations
  
  
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  Develop and approve procedures for new equipment being introduced into the plant.
  
  
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  Support new product transfer by creation or revision of the Process Consumable List
  
  
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  Create and or revise item specifications packages, work with vendors in obtaining the required documentation to support item specifications, and development of new drawings in support of item specifications.
  
  
  Qualifications Requirements/Knowledge/Education/Skills:
  
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    Bachelor's degree in science, Engineering, or other related field and 1 year of technical experience.
    
    
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    Excellent oral and written communication skills, and interpersonal and organizational skills.
    
    
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    Strong leadership skills.
    
    
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    Ability to train others to perform to cGMP standards.
    
    
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    Proficient with Microsoft Office applications.
    
    
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    Good self-discipline and attention to detail; ability to work under minimal supervision.
    
    
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    Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift hours and weekends as required.
    
    
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    Experience working in cleanroom environments under sterile or aseptic conditions; must have experience in engineering standards required for this type of operation.
    
    
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    Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
    
    
    Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibir--n consideraci--n para el empleo sin importar raza, color, religi--n, sexo, orientaci--n sexual, identidad de g--nero, informaci--n gen--tica, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
    Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Keywords: Mentor Technical Group, College Station , Process Engineer (Biopharmaceutical Industry), Engineering , College Station, Texas