QA Validation Associate

Responsibilities

• Provide quality oversight for validation activities related to products, facilities, utilities, and equipment (FUE).
• Support the development of validation plans and review project lifecycle documentation including URS, RA, and qualification protocols.
• Assist in the development and implementation of validation master plans, guideline documents, and SOPs.
• Participate in the change control program for modifications to qualified systems.
• Lead and represent QA Validation in multi-departmental meetings and project teams.
• Identify and resolve issues through robust root cause analysis and risk management approaches.
• Provide quality oversight for the Revalidation Evaluation program.

Requirements

• Bachelor of Science degree or higher in a technical discipline (physical, engineering, chemical, or biological sciences).
• 3+ years of experience in a cGMP regulated manufacturing environment.
• Proven knowledge of equipment and utility validation, as well as laboratory systems.
• Familiarity with FDA and European regulatory requirements and guidelines.
• Proficiency in technical summary report generation.
• Strong organizational and management skills to coordinate multi-discipline project groups.
• Ability to present data and defend technical approaches during regulatory inspections or audits.

About the Company

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the company has a proven track record of innovation, using a distinctive approach to drug discovery and development to impact patients worldwide.