FUJIFILM Biotechnologies is looking to solve technology transfer support and technical oversight during manufacturing operations as it relates to process analytics data management systems and trending purposes in their biopharmaceutical manufacturing facility.
Requirements
- Knowledge of Snowflake and Python
- Familiarity with machine learning techniques, data science techniques, and PAT
- Knowledge of regulatory requirements for data integrity
- Familiarity with data analytics architectures (e.g., warehousing, distributed computing, visualization analytics)
- Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
- Experience with structured query language (SQL) writing skills
- Experience with SPC and multivariate analysis
Responsibilities
- Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed
- Builds and maintains routine statistical process control methods and multivariate models for process trending and monitoring
- Supports ad hoc statistical analysis, as needed
- Closes deviations and provides thorough findings to internal teams
- Documents process performance and product health through process trending, monitoring, and supporting annual product reviews and manufacturing campaign summary reports
- Supports technical risk assessments for new manufacturing processes from a process analytics (PA) perspective
- Trains relevant stakeholders on PA tools and respective analytical approaches (e.g., multivariate models, Process Analytical Technologies (PAT), and Statistical Process Control (SPC) methods), as needed
Other
- Bachelor’s degree in Data Science, Biotechnology, or Chemical Engineering with 2 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or Master’s degree with no prior experience
- Ability to develop effective working relationships internally
- Effective communication, both written and oral
- Analytical and problem-solving, and project management skills
- Ability to stand for prolonged periods of time. 30 minutes
