Job Overview
This role is responsible for coordinating and managing process validation activities in a cGMP environment. The Process Validation Associate will work with cross-functional teams to implement new manufacturing processes and changes to existing processes.
The successful candidate will have experience in a cGMP regulated manufacturing environment, with knowledge of process validation, process sciences, and change control. They will also possess organizational and management skills to participate in multi-discipline project groups.
* Perform process validation activities related to BioMarin's drug substance and drug products.
* Execute process validation activities related to the implementation of process changes and new processes.
* Assist with preparation of regulatory filings and presentations during regulatory inspections/partner audits.
The ideal candidate will have a strong understanding of industry standards and regulatory requirements for products developed and manufactured by BioMarin. They will also be able to identify and assist with implementation of improvements to Process Validation systems.
This position requires the ability to utilize a computer to perform tasks and interact with multiple levels of employees in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Technical Development, Facilities, Regulatory Affairs, and People Resources.