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.
The Engineer II will be responsible for developing and managing applications and interfaces for the capture and reporting of cGMP manufacturing and lab-based data as well as recommending and implementing changes to systems. The candidate will assist in defining a global data management strategy, provide input into the long-term direction of data applications, and assist with data mining and analysis requests from groups within Technical Operations.
The position requires expertise in programming (SQL, Python, and other languages as applicable) and data mining and ETL workflows. Familiarity with data historians (e.g. OSIsoft PI), Oracle databases, biotech applications (e.g. Sartorius Stedim SIMCA), pharmaceutical manufacturing processes are desired. Experience with Statistical Process Control, multivariate analysis (e.g. Discriminant Analysis, Partial Least Squares Regression), development of statistical models (e.g. Monte Carlo simulations), or Business Data Analyst experience is a plus.
The candidate must unite strong programming and technical skills with a knowledge of processes for the manufacture of biologics, an understanding of cGMP, process development, validation and tech transfer. The individual must have strong interpersonal skills, and a proven ability to work independently in a dynamic, multidisciplinary environment.
- Managing and improving existing data management tools and applications by gathering user requirements, designing architecture and developing code.
- Project cycle management and execution for supported application improvements.
- Assists in defining a global data management strategy and data application vision.
- Support routine requests for data mining and complex data analysis.
- Work independently while supporting and interfacing with multiple groups including Manufacturing Sciences, Process Sciences, Manufacturing, IM, Quality, Automation, Validation, & Facilities.
- Prepares operating instructions, documentation and training materials as well as delivers training on developed and supported systems.