Senior QA Validation Associate

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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.

• Key Subject Matter Expert (SME) and Quality Oversight representative in specific validation discipline(s).
• Maintains current knowledge of industry standards and regulatory requirements for validation techniques / approaches utilized at BioMarin.
• Supports the QA Validation group in maintaining regulatory compliance, in line with industry best-practices in specific validation discipline(s).
• Supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise.
• Supports strategy development and ensures regulatory compliance for validation projects. Strategically supports complex validation projects across a variety of disciplines.
• Provision of mentorship and SME support to more junior members of the QA Validation team and cross functional groups as applicable.
• Lead and represent QA Validation in multi-departmental meetings & project teams.
• Identifies and leads implementation of improvements to validation systems. 
• Quality Oversight for Validation execution activities related to the various validation disciplines. This includes supporting and reviewing / approving validation lifecycle documentation e.g. URS, Risk Assessments, Commissioning Documents, Qualification Protocols, Revalidation / Periodic Review Reports.
• Supports development of validation plans for specific system implementation projects.
• Establishes site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures. 
• Provide Quality Oversight for any assigned change requests, deviations, quality events and associated CAPAs. 
• Other duties as assigned.
  
  

• Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

• +5 years’ experience in a cGMP regulated manufacturing environment, with demonstrated knowledge of facility, equipment, utility, process, lab systems and CSV validation.
• Organizational and management skills to coordinate multi-discipline project groups
• Ability to speak, present data, and defend approaches in front of audiences and inspectors.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
• Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
  
  

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.