Engineer/Scientist 2, Process Analytics

Fujifilm•Holly Springs, NC

40d

About The Position

The Engineer / Scientist 2 of Process Analytics provides technology transfer support and technical oversight during manufacturing operations as it relates to process analytics data management systems and trending purposes. This role supports senior team members in all aspects of process analytics, including but not limited to closing deviations, generating master batch records, and data system improvement initiatives.

Requirements

Ability to develop effective working relationships internally
Effective communication, both written and oral
Analytical and problem-solving, and project management skills
Knowledge of project management concepts
Ability to present information to others
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)
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
Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)

Nice To Haves

Experience working in a GMP environment
Experience with structured query language (SQL) writing skills
Experience with SPC and multivariate analysis
Experience working with process historians and data management systems (e.g., OSI PI, Statistica, SIMCA)

Responsibilities

Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed
Coordinates with cross-functional teams to deliver projects on time and in full completeness
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
Serves as on-call for PA issues and concerns
Supports role in Good Manufacturing Practices (GMP) environment
Provides technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
Supports generation and review of master batch records (MBRs) and sample plans, as needed
Participates in site data stewardship activities by ensuring data and analyses are easily findable, accessible, interoperable, and reusable to internal and external stakeholders
Supports informatics, data systems improvement initiatives, and evaluates new analytical technologies (e.g., PAT, data science tools) and solutions to improve scalability, manufacturability, reliability, yield and cost
Supports the curation of critical knowledge related to PA systems and multivariate modeling
Identifies improvement opportunities and assists in the development of business cases and improvement plans
Participates in writing and reviewing standard operating procedures (SOPs), work instructions, protocols, and other relevant documentation
Builds awareness of industry trends and customer requirements
Supports the design of sampling protocols and sampling plans supporting PAT and analytics development
Other duties, as assigned