Engineer 1/2 - MSAT Process Modeling

Location:  Novato, California Category: Manufacturing Science and Technology

Description

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.