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Intern, Computerized Systems Audit Specialist

BioMarin Pharmaceutical Inc.
Working from Home
Start date
Mar 22, 2023

View more

Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time

Job Details


The GxP Computerized Systems Audit Specialist is responsible for assisting with the planning and execution of audits related to Computerized Systems Data Integrity (CSDI) to assess ongoing compliance with government regulations and corporate standards. This position will provide support to audit leads and management around the conduct of audits for vendors involved in the supply of software used by Biomarin for the management of clinical, pharmacovigilance and commercial manufacturing data and in accordance with GxP applications.


Required Skills:

  • Understanding of computerized software systems used to manage company critical data
  • Understanding of data integrity concepts and approaches
  • Experience with risk-based management of software systems
  • Ability to review and identify potential systemic gaps with respect to the conduct of software vendor audits based on risk
  • Software validation experience an advantage
  • Regulatory knowledge around data integrity requirements an advantage (i.e. US FDA, MHRA, EMA, PIC/S)

Desired Skills:

  • Project management experience
  • Experience with procedural implementation (i.e. SOPs)
  • Experience with software vendors providing services to the pharmaceutical industry


  • Student in their of 4th year pursuing either Bachelor’s Degree or a Master’s Degree in Computer Science or Business
  • Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program.
  • Must be available to work 40 hours a week
  • Must be authorized to work in the United States without visa sponsorship

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 skills specific to your major.
  • Opportunities for professional development by building relationships and learning about other parts of the business.
  • Weekly Speaker Seminar Series with Executive Staff.

In the U.S., the hiring range for this position is $ 21.00 to $ 30.00 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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


BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

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