Engineer 1/2 - Msat Process Modeling

Biomarin Novato , CA 94998

Posted 7 months ago

Engineer 1/2 - MSAT Process Modeling Location Novato, California Apply

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. Come join our team and make a meaningful impact on patients' lives.

Summary:

This is an open position in MSAT's Process Modeling group, a team whose mission is to demonstrate the current and potential capabilities of BioMarin's manufacturing network. As an engineer on our team, you will own and contribute to the following core responsibilities of Process Modeling:

  • Capacity planning and assessment of plant utilization

  • MFG productivity data generation

  • Constraint identification, debottlenecking, and optimization of MFG processes

  • Process change impact assessments

  • Strategic network scenario capacity assessments

  • Scale-up and facility fit; tech transfer support for new processes

The candidate will apply their technical knowledge of biopharmaceutical processes (cell culture, purification, etc.) and engineering experience to build and maintain models for commercial, clinical, and pipeline products. The candidate will document analyses, results, and recommendations in internal memos, reports and/or oral presentations, and strong communication skills are required. This position requires strong independent work as well as collaboration with SMEs and customers throughout the Technical Operations organization.

Responsibilities:

  • Process modeling of biologics manufacturing using Bio-G Real Time Modeling Software (RTMS); developing models and executing simulation analyses

  • Generation of simulation data to provide Manufacturing and Supply Chain with critical information necessary to maintain consistent product supply, now and in the future

  • Ongoing maintenance of process models and related tools

  • Analysis of historical data and incorporation into process models using Crosswalk Designer

  • Support of custom tools used to analyze aggregated simulation outputs in a format useful to a broad user base (i.e. VBA macros in Excel)

  • Author documents including work instructions for the RTMS user base, memos/reports with analysis findings and recommendations; prepare oral presentations

  • Support MFG Network Strategy initiatives as Capacity Planning SME

  • Work independently while supporting and interfacing with multiple groups including Manufacturing, Manufacturing Sciences, Engineering, Process Development, Quality, Facilities, and Supply Chain

Education:

Minimum Bachelor's degree in Chemical Engineering or similar engineering discipline

Experience:

  • BS with 2-6 years of experience in process engineering or cGMP manufacturing

  • Detailed understanding of biologics manufacturing unit operations, including cell culture, fermentation, and purification processes

  • Process simulation, data mining and analysis

  • Strong verbal and written communication skills

  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Power Point, MS Visio

  • Experience with RTMS, Crosswalk Designer, VBA (i.e. Excel macros), OSI Pi, process scale-up/scale-down, tech transfer are a plus

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Business Process Analyst 2

Biomarin

Posted 2 weeks ago

VIEW JOBS 9/26/2019 12:00:00 AM 2019-12-25T00:00 Business Process Analyst 2 Location Novato, California Apply 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. Come join our team and make a meaningful impact on patients' lives. SUMMARY We are looking for a skilled, innovative Business Process Analyst 2as we mature and scale our business processes to support future growth. You will directly contribute to the success of the Novato operations site in our mission of producingtherapeutics for the treatment of rare diseases. This role reports through Business Operations and supports all of the local Make – Assess – Release functions,which includeapproximately 600 employees. You will lead continuous improvement projects, through development and implementation, to drive reliable and resilient processes and operations. The position will have wide influence and impact over Manufacturing, Facilities/Engineering, QC and QA. This position is a dynamic and rewarding position that requires a high degree of professional, collaborative interaction, self-awareness and an innovative spirit. RESPONSIBILITIES Detailed responsibilities include but are not limited to the following: * Leading continuous improvement projects: * Identify gaps and inefficiencies to current state business processes. * Identify opportunities for improvement and the desired future state. * Prioritize opportunities based on business drivers. * Partner with cross-functional project teams to implement improvements. * Recognize barriers to improvement efforts and work to remove them. * Generate project charter, SIPOC, project schedule, impact/effort matrix. * Execute on kaizen, 5S, root cause analysis events. * Completing projects by agreed upon due dates. * Shares learnings across the organization. * Supporting root cause analyses. * Collecting and reporting metrics. * Continued development and training (self) in Operation Excellence (OE) competencies. EXPERIENCE Required Skills * BS with minimum 2-3years' experiencein a regulated environment * 1 - 2years of continuous improvementor relevant experience with a proven track record of successfully leading cross-functional initiatives. * Demonstrated ability to partner with other functional groups and skilled in leading people through business change. * Experience in public speaking and leadership/motivation roles is preferred * Excellent communication skills and experience facilitating * Ability to comprehend technical process information. * Ability to work independently, contribute in teams and lead teams. * Ability to quickly grasp and synthesize information across a variety of disciplines to create a strategic plan to achieve business objectives. * Knowledge of drug manufacturing is preferred * Working knowledge of electronic GMP systems, (Oracle EBS, SAP, Trackwise, LIMS, etc.), is preferred * Working knowledge of Minitab or JMP statistical software is preferred EDUCATION Required Education * BA or BS in a technical discipline (physical or biological sciences or engineering preferred but not required) with 3-5 years related to pharmaceutical manufacturing * MS in a technical discipline (physical or biological sciences preferred but not required) with 2+ years related to pharmaceutical manufacturing * Training in Lean Six Sigma/continuous improvement Preferred Education * Lean Six Sigma green belt certification * Project Management Institute (PMI) or Project Management Professional (PMP) certification. Biomarin Novato CA

Engineer 1/2 - Msat Process Modeling

Biomarin