Process Engineer 1Location Novato, California Workstyle Open to Hybrid Apply
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.
Novato Engineering and Facilities Services (NEFS) commitment is to meet or exceed BioMarin customers' and stakeholders' expected level of service by supplying leadership, technical knowledge and innovation to advance a safe, compliant, healthy, and environmentally responsible culture. In addition, the Process Engineer – NEFS takes responsibility for the lifecycle management of all company assets we are entrusted with.
This position will support upstream processes in our Galli North manufacturing plant.
- Provide technical engineering support to the Drug Substance and Drug Product
- Manufacturing process including process performance monitoring, troubleshooting and process optimization
- Provide technical engineering support to ensure successful technology transfers of new products
- Support engineering design and optimization of single use consumables.
- Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
- Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimization using tools such as DMAIC, SMED and FMEA.
- Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly.
- Author Area Deviation investigations as required to support the Process Team
- Identify and implement CAPA’s stemming from area investigations
- Generate CR’s for change controls impacting the Process Team Area
- Own direct process equipment physical configuration and CMMS activities
- Procure and commission process analytical and small support equipment
- Participate in area Process Characterization Risk Assessment (PCRA) strategy for parameters and equipment capability
- Develop documentation for internal projects as well as reviewing/approving vendor supplied documentation (User Requirements, Functional Specifications, Software Design Specifications, and Software Test Plans)
- Support manufacturing, utilities, and laboratory users by assessing their needs for the system and execute independent projects to meet those needs.
- Contribute to batch reporting projects/assignments in the support of site operations through requirements gathering, design support, report technical implementation, and test execution. Proactively look for and recommend improvements in site processes and procedures.
- System programming, configuration and maintenance
- Familiarity with Veeva, CMMS & Trackwise applications
- BS or MS in Chemical, Mechanical, or other Engineering degree from an accredited university. Relevant job and years of experience may be substituted in place of a degree.
- A minimum of 3 years’ experience in processes, facilities clean utilities and/or plant utilities, preferably in the biotechnology or pharmaceutical industry.
- Experience with executing commissioning and qualification activities.
- Strong organization, interpersonal, oral and written communication skills.
- Proficiency with standard office software applications, including MS Word, MS Excel,
- MS Project, MS Power Point, MS Access.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.