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.
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.
- 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.
- 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
- 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.)
- 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.