Process Engineer 2 / 3
Company: BioMarin Pharmaceutical Inc.
Posted on: May 14, 2022
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
- Provide technical engineering support to the Drug Substance and
- 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
- 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
- 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
- Identify and implement CAPA's stemming from area
- Author area Calibration QE's and Calibration Deviations for
area owned equipment
- Generate CR's for change controls impacting the Process Team
- Own direct process equipment physical configuration and CMMS
- Procure and commission process analytical and small support
- 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
- 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
- Support and/or execute acceptance testing and protocols that
are used in the validation of our equipment and control
- System programming, configuration and maintenance
- Familiarity with Veeva, CMMS & Trackwise applications EDUCATION
- 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. EXPERIENCE
- 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
- Strong organization, interpersonal, oral and written
- 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.
Keywords: BioMarin Pharmaceutical Inc., Novato , Process Engineer 2 / 3, Engineering , Novato, California
Didn't find what you're looking for? Search again!