Intern, GxP Computerized Systems Audit Specialist
Location United States, RemoteWorkstyle Remote Only Apply
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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.
The GxP Compliance Audit team is responsible for maintaining adherence to industry regulations through independent, risk-based assessments. The team leads multiple audit types internally and with domestic and international third parties, including but not limited to suppliers, contract manufacturers, contract laboratories, software vendors, commercial distribution partners and key service providers.
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.
- 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)
- 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.
In the U.S., the salary range for this position is $ 0 to $ 0 per year, which factors in various geographic regions. 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. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.