EngineerScientist 2, Process Analytics

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

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

Knowledge and Skills

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)

Basic Requirements

Bachelors degree in Data Science Biotechnology or Chemical Engineering with 2 years of relevant experience (e.g. data
engineering manufacturing bioprocess development PAT); or
Masters degree with no prior experience
Experience using Quality Systems (e.g. Deviation Management system Change Control CAPA document management system)

Preferred Requireme

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)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.
Ability to stand for prolonged periods of time. 30 minutes
Ability to conduct activities using repetitive motions that include writs hands and/or fingers.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Position OverviewThe 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 pro...