Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

Our Culture

It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.

• Have a keen sense of responsibility to patient safety, product quality, and end user satisfaction.
• Thrive in a fast paced, constantly evolving environment
• Question assumptions and enjoy solving process and technical problems using critical thinking and analytical skills
• Possess a high level of initiative, energy, motivation, and organizational skills.
• Partner and engage stakeholders and other IT peers to manage the overall requirements and lead the implementation of strategic laboratory enterprise applications and systems/equipment. 

• Technical ownership of lab applications 
• Perform second level application support, routine administration, and Master Data maintenance
• Perform investigations and root cause analysis
• Perform technical lead duties for implementation projects
• Host/manage regular Super User meetings to gather new enhancement requests, identify training opportunities, and communicate status updates key users
• Ensure users understand and accept the solutions delivered to them by facilitating UAT, performing demonstrations, and Conference Room Pilots
• Assist with validation (risk assessments, technical guidance, discrepancies, Uses Cases etc.)
• Support the validation of applications including but not limited to risk assessments, URS, UAT, Qualification Reports, template verifications, Baseline configurations, Change Control, SOPs updates, System Retirement Plans & Protocols, validation reports. 
• Maintain current knowledge of industry standards and regulatory requirements for computerized systems 
• Identify and implement improvements to IT applications where appropriate 

• Minimum 2 years experience in a GxP regulated environment supporting and implementing applications as an Administrator (e.g. LIMS, Empower, SoftMax)
• Experience with Change Control, Deviations, CAPA, Validation, 21CFR Part 11/EU Annex 11 and related record management applications (VEEVA, Trackwise, ALM)
• Positive, clear, effective verbal and written communication skills including the ability to direct consensus, resolve conflicting interests, and communicate laterally across departmental boundaries
• Design, definition, and management of Master Data
• Technical troubleshooting and end user support skills
• Technical Documentation (SOPs, SDLC, Process Mapping)
• Understanding of GMP predicate rules and Data Integrity concepts
• Experience with application deployment methodologies in a regulated environment (GAMP 5, Risk Analysis, Waterfall, Agile etc.)

• Experience and knowledge of Business Analysis techniques
• LabWare configuration skills, SQL, Crystal Reports knowledge
• Basic programming knowledge
• Experience administering Empower, SoftMax Pro, WinKQCL, and benchtop applications

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.



An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.