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.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
The Engineering Validation Associate reports to the Commissioning Qualification and Validation Manager, day to day technical direction may be delegated to the Engineering Validation Team Lead as required, and is responsible for fulfilling validation activities in a GxP regulated environment, including implementation of laboratory systems, new manufacturing equipment/processes and changes to existing equipment/processes.
Key Responsibilities
In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control.
Develop validation plans for specific system implementation projects.
Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
Lead and represent validation in multi-departmental meetings and project teams.
Identify and implement improvements to the Engineering Validation systems.
Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
Other duties as assigned.
Key Requirements
8-10 years of Industry Experience.
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.
Equal Opportunity Employer/Veterans/Disabled
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.
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