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FUJIFILM Biotechnologies · 2 weeks ago

Engineer/Scientist 2, Process Analytics

Holly Springs, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina, and is seeking an Engineer/Scientist 2 for Process Analytics. This role provides technology transfer support and technical oversight during manufacturing operations, focusing on process analytics data management systems and trending purposes.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

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

Qualification

Data ScienceProcess Analytical Technologies (PAT)Statistical Process Control (SPC)PythonSQLMachine LearningData Analytics ArchitecturesAnalytical SkillsProject ManagementEffective CommunicationProblem-Solving

Required

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)

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)

Preferred

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)

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)