Packaging, Bioprocess Specialist

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

Closing date: Tuesday 9th June 2026

The Packaging BioProcess Specialist – Packaging Operations reports to the Packaging Operations 
Manager and works in a team environment that will be committed to continuous improvement, process understanding, personal development and demonstration of production techniques that will result in agile and compliant packaging operations. 
GMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and 
maintaining BioMarin’s innovative manufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients. 

KEY RESPONSIBILITIES 
• Support and partner closely with peer groups to ensure master batch records, SOPs, training 
records and other documents are current and compliant under cGMP conditions – ensure 
Manufacturing systems and practices are consistent throughout the organization 
• Own, investigate, write and approve associated deviations as well as support & coach Packaging 
Technicians in these functions – ensure adoption of ‘zero late’ mentality in meeting timelines. 
• Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution. 
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and 
regulatory compliance. 
• Partner with validation subject matter experts, prepare/approve validation protocols, validation 
plans, protocol executions, and summary reports in support of ongoing revalidation and 
validation efforts required for commercial manufacturing. 
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues 
using root cause analysis tools 
• Develop, define scope and support the implementation of technical solutions under the 
guidance of site change control systems. 
• Perform desk-based tasks as required. For example, MES exception closure, deviation 
investigation or other administrative tasks. 

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.