Sr. Process Engineer, MSAT Technology Development ( Single Use Technology )
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. Come join our team and make a meaningful impact on patients’ lives.
This position requires the utilization of basic engineering and manufacturing principles relevant to biopharmaceutical processes with an emphasis on technology development. Technical expertise in manufacturing systems and materials is required in order to provide support to Commercial and Clinical manufacturing operations as well as Process Development operations. This position requires a detailed knowledge and understanding of single use technologies, applications, and supplierss. Employee will lead, develop, and implement process improvement initiatives consistent with cGMPs via evaluation of current practices and process history, and via evaluation of new equipment, methods, and technologies. He or she will lead maintaining and troubleshooting existing processes by having a detailed understanding of the processes, and the equipment and materials used to perform them. He or she will support transfer of new processes from Process Development into a cGMP Manufacturing environment. He or she will utilize existing methods and tools (TrackWise, Veeva, etc.) to implement new materials or processes, or to make changes to existing materials or processes. He or she should be detail oriented while also operating with a broad strategic perspective.
This position involves close collaboration with several key groups within Technical Operations including, but not limited to, Clinical and Commercial Manufacturing, Process Development, Material Operations, Novato and Global Engineering (Process, Automation), Supply Chain, Global Supplier Quality, Capital Project Management, Quality Assurance (Validation, Operations, Raw Materials), Compliance, and Regulatory Affairs.
Periodic travel may be required to attend relevant professional conferences, workshops, or trainings, support technical transfer, and evaluate systems, processes, and technologies.
•Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives and/or projects with an emphasis on single use items and technologies
•Assist in the development of site/company standard technology platforms
•Support vendor audits and factory and site acceptance testing
•Assess raw material change notifications, complaints, etc.
•Lead investigations into single use material deviations and/or abnormal events and manage subsequent corrective actions and changes
•Evaluate and/or test the feasibility of new manufacturing processes, materials, and technologies
•Participate in the execution of small-scale validation studies to establish a broad library of approved and/or accepted technologies, vendors, etc.
•Responsible for technical evaluation of proposed technology changes to Manufacturing processes
•Support technology and process transfer to and from the Manufacturing areas or facilities to ensure developing processes align with established large-scale and/or Commercial Manufacturing technology practices
•Manage single use change requests, CAPAs, FUAs, and Action Items via TrackWise
•Oversee project milestones, departmental goals, and carry out strategic initiatives
•Communicate progress and status of projects clearly and effectively
•Create projects, spreadsheets, and presentations via Microsoft Office programs
•Continued education on understanding of new technologies and relative equipment operation
BS in Life Sciences with 2-5 years of experience or MS with 0-3 years of experience in Manufacturing Sciences and Technology, Process Engineering, or cGMP Manufacturing
•Strong knowledge of and expertise with single use technologies
•Strongly established working relationship with key single use vendors and company single use support groups is recommended but not required
•Basic understanding of engineering principles relevant to biopharmaceutical processes and equipment used to support manufacturing operations
•Strong technical understanding of general biopharmaceutical manufacturing processes and techniques (bioreactor operations, depth filtration, media/buffer preparation, clean/steam in place operations, single use technologies, etc.)
•Experienced in the transfer of processes and technology to cGMP and/or clinical operations
•Experienced in cGMP and with large-scale manufacturing equipment and practices
•Knowledge and understanding of regulatory agency guidelines, expectations, and best practices
•Proven project management, organizational, and communication skills
•Proven ability to independently manage work, actions, and expectations
•Proven ability to handle multiple tasks concurrently and be flexible and adaptable
•Proven ability to meet deadlines
•Strong knowledge of and experience using Microsoft Office programs (Project, Excel, PowerPoint)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.