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GxP Application Specialist (TEMPORARY)

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.


The GxP Application Specialist will implement Instrument based software (COTS) in the Quality Control labs. The Application Specialist is a hands on, individual contributor that will help ensure that systems are implemented efficiently (following a standard process) so that the lab can maintain a high standard of efficiency and compliance with current data Integrity requirements.


    • Coordinate projects and manage deliverables across multiple departments (QA, QC, IT etc.).

    • Research software functionality for COTS systems to determine suitability and capability of meeting user requirements

    • Configure software using the standard ‘out of the box’ interface

    • Draft SDLC documents including FRS, UAT and Test Cases

    • Provide content for 'end user' SOPs, work instructions and training materials

    • Document, and communicate project outcomes (Positive/Negative) to management and participate in efforts to improve the process.

    • Assist in ad-hoc projects as needed to address QC Informatics deviation investigations or initiatives.

    • Perform Post-Go live application support


Must Have:

    • Project coordination experience and organization skills.

    • 3 years in a Pharmaceutical/Biotech environment preferably with either lab experience or software implementation experience

    • Positive communication skills (written and verbal), including lateral management, meeting management, and negotiation skills.

    • Microsoft Office (or similar) application skills

    • Minimum 1 year of Systems Analysis experience, including troubleshooting and root cause analysis

Highly Desired Experience:

    • Common software solutions used in the QC lab (SoftMax Pro, Empower, LIMS, ELN,  etc)

    • Standard software development methodologies (Agile, Waterfall, etc.)

    • 21CFR Part 11, GAMP, ALCOA+


Minimum: BA/BS degree OR six years direct experience in a similar role

Additional Desired: PMI and/or ASQ (CSQE) certification

Skills and Experience

The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.

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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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