Senior QA Validation Associate

Responsibilities

• Act as a Subject Matter Expert (SME) and provide quality oversight for validation activities in a GMP regulated environment.
• Review and approve validation lifecycle documentation, including URS, Risk Assessments, Commissioning Documents, and Qualification Protocols.
• Support the development of validation plans, site validation master plans, and standard operating procedures.
• Provide quality oversight for change requests, deviations, quality events, and associated CAPAs.
• Lead and represent QA Validation in multi-departmental meetings and project teams.
• Support complex investigations, regulatory submissions, and agency inspections.
• Mentor junior members of the QA Validation team and cross-functional groups.

Requirements

• Bachelor of Science degree or higher in a technical discipline (physical, engineering, chemical, or biological sciences).
• 5+ years of experience in a cGMP regulated manufacturing environment.
• Demonstrated knowledge of facility, equipment, utility, process, lab systems, and CSV validation.
• Familiarity with FDA and European regulatory requirements and guidelines.
• Proven ability to present data and defend technical approaches to audiences and inspectors.
• Strong organizational skills with the ability to coordinate multi-discipline project groups.

About the Company

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 success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities.