Join to apply for the Engineering Validation Associate role at BioMarin Pharmaceutical Inc.
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.
Our Technical Operations group creates drugs for use in clinical trials and scales production for the commercial market. These engineers, technicians, scientists and support staff build and maintain cutting‑edge manufacturing processes and sites, provide quality assurance and quality control, and procure the needed goods and services to support manufacturing and coordinate worldwide movement of our drugs to patients.
Key Responsibilities
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) in collaboration with plant support functions.
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 SOPs.
Prepare and track completion of assigned change requests, deviations, quality events and associated CAPAs.
Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
Assist with preparation of regulatory filings and participate during regulatory inspections/partner audits.
Maintain current knowledge of industry standards and regulatory requirements for BioMarin‑developed or manufactured products.
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 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.
Seniority Level
Mid‑Senior Level
Employment Type
Full‑time
Job Function
Engineering and Information Technology
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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