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Lab Systems Specialist

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Dec 2, 2023

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Job Details

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

DEPARTMENT SUMMARY

The RED Laboratory Operations Data Integrity Group at BioMarin Pharmaceutical Inc liaises between scientific groups in RED (Research and Early Development) and internal and external groups to 1) identify and implement technology solutions that meet business needs and drive science; 2) influence timely and traceable electronic notebook writeups, presentations, and reports; with source data references; and 3) ensure data integrity meets CFR standards on validated equipment and lab systems.

The Technology Solutions and Lab Data Integrity Specialist II in the RED Lab Operations group at BioMarin Pharmaceutical Inc. will implement instrument systems and software that meets business needs of WWRD. The Technology Solutions and Lab Data Integrity Specialist will help ensure systems are implemented efficiently, following a standard process, so that the lab is delivered systems that meet business needs, enhance compliance, improve efficiency, and reduce regulatory risk.

Individual will also work closely with the RED groups and scientists and with other functional groups at BioMarin.

RESPONSIBILITIES

  • Partner with lab users and business SMEs to define business needs and user requirements and articulate requirements to internal and external collaborators.
  • Analyze, develop, and document data flows/process maps.
  • Determine system implementation feasibility.
  • Interface instruments and instrument workstations with systems/software.
  • Develop test cases for GxP and non-GxP systems/software.
  •   With minimal guidance, draft project implementation plans, requirement specifications, and execution of test scripts for system validation implementation projects according to applicable GLP and 21CFR Part 11 compliance regulations and ensure system meets business needs. Resolve defects.
  • Perform POC (Proof of Concept) testing.
  • With minimal guidance, prepare, review, and obtain approval of controlled documents, process documents, and data reports including but not limited to SOPs, Work Instructions, training materials and SDLC documentation such as System Design Documents and System Configuration.
  •   Ensure Lab data integrity by maintaining accuracy, control, traceability, and retrievability of data per 21 CFR Part 11 and Part 58 Data Integrity and Archiving requirements, as appropriate.
  • As needed, coordinate with RED personnel and IM Scientific Platform Lab Support personnel to maintain and troubleshoot instrument workstations troubleshooting.
  •   As needed, perform system administration and configurations as well as resolve technical issues for RED Enterprise systems (such as LIMS, ELN, and SDMS), analytical instruments, and other software.
  •   Provide post-Go-Live system/application support.
  •   Assist in ad hoc projects as needed.

SKILLS/EXPERIENCE

Must Have:

  • Ability to plan and prioritize assignments effectively to meet timeline commitments.
  • Self-motivation and be a quick learner of business processes and technology.
  • Strong interpersonal communication skills including meeting management, negotiation/persuasion, and conflict resolution.
  • Experience implementing and managing COTS, simple, custom, complex solutions used in the RED lab (SDMS, LIMS, ELN, Benchling, instrument software, etc…)
  • 5 years direct experience implementing/validating software in a regulated environment.
  • 2 years experience in a laboratory environment
  • Versatility with Microsoft Office (or similar) including Word, Excel, PowerPoint, Visio, and Project

Highly Desired:

  • Experience in generating data flows, process flows, SDLC deliverables particularly URS, FRS, Config Spec, Test Scripts
  • Experience in Computer System Assurance/ Computer System Validation
  • Experience initiating and managing change control and deviations requests
  • Experience/knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA)
  • Experience in standard software development methodologies (Rapid, Waterfall, etc.)

EDUCATION

  • Minimum: BA/BS degree in either Life Sciences (Microbiology, Biology, Biochemistry, Analytical Chemistry, etc…)  or Computer Science/MIS related degrees ~ Or a minimum of 8 years direct experience in a similar role with escalating levels of responsibility will be considered


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.

Company

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.

Company info
Website
Location
California
United States

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