Sr. Process Engineer II

Profile

Who We AreBioMarin’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.This position will serve as a member on the Galli North Upstream Process Team.California Facilities and Engineering (CFE) 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 – CFE takes responsibility for the lifecycle management of all company assets we are entrusted with. Role: Sr. Process EngineerRESPONSIBILITIES· 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 applicationsSCOPEThis role is critical in the support of Novato Make, Assess, Release GMP operations. 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 10 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. WORK ENVIRONMENT / PHYSICAL DEMANDS· While primarily a day shift office/computer-based job, hours will vary based on the needs of the position, with some work in field (labs, manufacturing plants, utility/maintenance areas, roofs, etc.). This position may require occasional overtime and weekend/holiday work depending upon various facility requirements.· Provide after-hours leadership/managerial on-call support as required.· While performing the duties of this job the employee is frequently required to stand, walk, sit, talk or hear, reach with hands and arms, climb stairs or ladders, balance, stoop, kneel or crouch.· Specific vision abilities required by this job include close vision, depth perception, color vision, peripheral vision, and ability to adjust focus.· While performing the duties of this job, the employee occasionally works in hot or cold areas, and in proximity to hazardous chemicals, or radioactive or biohazardous waste.· The noise level in the work environment is usually moderate.· The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. When required, the company will provide personal protective equipment (PPE), and employee is expected/required to use it.EQUIPMENT· Typical office hardware and software, which includes the basic suite of Microsoft business applicationsCONTACTSThis position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.The Engineer will work closely with other support groups such as Engineering, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Instrumentation, Global Engineering, EHS&S, Quality Assurance and Quality Control to ensure that BioMarin assets are well managed throughout their lifecycle. SUPERVISOR RESPONSIBILITY-No direct reports at this time.-Lead other Engineers from the team as required. Engineers can be assigned to work with the Engineer to support relevant activities in their area.-Lead external consultants to complete critical activities and deliver compliant work on time and to budget.CAREER DEVELOPMENT· Act as a champion and change agent in support of the Engineering Department and other BioMarin continuous improvement efforts· Provide insightful and strategic input during Long Range Planning efforts· Demonstrate the ability to effectively work in both tactical and strategic environments· Be perceived as a strong candidate when a mentoring or coaching opportunity arises· Demonstrate the ability to engage, motivate and positively influence others’ in the pursuit of achieving BioMarin goals and objectivesPLEASE 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.

Company info

BioMarin Pharmaceutical Inc.
Website : http://www.biomarin.com