Intern, QA Global Validation - Computer Systems Validation

Location:  Novato, California Category: Quality Employment Category: Fulltime-Temporary

Description

SUMMARY:

The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry.

Quality Risk Management (QRM) process improvement to provide BioMarin Q Team a solid methodology on how to manage cumulative risks throughout systems lifecycle.  Technical solution will be translated into procedures and will be applicable to new and existing systems for TOPS.  Quality risk management application will be defined for Strategic Planning and Project Initiation, Commissioning and Qualification, and Quality Systems to provide a cross functional risk management approach.  This project will improve the overall QA validation and systems lifecycle processes by reducing the probability of risk occurrence to ensure timely delivery of high-quality products to patients.

 

JOB DESCRIPTION:

RESPONSIBILITIES

 

  • Define Risk Assessment methodologies applicable for Quality, Computer Systems and Bioprocesses.
  • Development of Risk Assessment procedure or guidance document for Quality, Computer Systems and Bioprocesses.
  • Assist in the execution of Quality Risk Assessments for Computer Systems Lifecycle.
  • Assist in the execution of Quality Risk Assessments for Data Integrity.
  • Support the planning and project managements of risk assessments activities.

 

EXPERIENCE

 

Required Skills:

 

  • Engineering Major - Undergraduate (Junior or Senior year).
  • Good verbal and written communication skills.
  • Technical Skills: 
    • Microsoft office (excel/word/outlook/project)
    • Computer software
    • Computer programming/software code.

 

Desired Skills:

  • Familiarity with Biotechnology and Pharma processes.
  • Familiarity with probability and risk management tools.
  • Familiarity with Information Technology/Information Management (servers, clouds, data management). 

 

EDUCATION

  • BS - Engineering or Information Management Major - Undergraduate (Junior or Senior year)

 

Notes:

  • Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the intern program 
  • Must be available to work 40 hours a week
  • Housing and Transportation is responsibility of the Intern

 

Benefits of a BioMarin Internship:

 

  • Apply skills and knowledge learned in the classroom to on-the-job experiences
  • Comprehensive, value-added project(s)
  • Work in teams and with colleagues in a professional environment
  • Develop technical skills specific to your major
  • Provides opportunities for professional development by building relationships and learning about other parts of the business
  • Weekly lunch seminar series with Executive Staff
  • End of summer poster presentation to the BioMarin Community


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.