Process Engineer 2 / Sr. Process Engineer
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 the Leveroni Down Stream Process Team.
- 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.
- Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities.
- Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly.
- Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
- Work collaboratively to drive safe, high quality, and cost-effective manufacturing facilities.
- Author Area Deviation investigations as required to support the Process Team
- Identify and implement CAPA’s stemming from area investigations
- Author area Calibration QE’s and Calibration Deviations for area owned equipment
- 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
- Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
- Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards.
- Maintains professional and technical knowledge by attending workshops, reviewing professional publications; establishing professional networks and participating in professional societies.
- 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.
- Create a line of communication with vendors to troubleshoot and problems solve issues within the environment.
- 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.
- Support and/or execute acceptance testing and protocols that are used in the validation of our equipment and control systems.
- 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 7 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.