Sr. Engineer 1, Process Analytics

Position Overview

The Senior Engineer 1 of Process Analytics provides support and leads technology transfer and technical oversight activities during manufacturing operations. This relates to process analytics data management systems, trending processes, and advanced analytic tools. This role leads and provides guidance to junior team members through all aspects of process analytics.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You’ll Do

• Leads the execution of site readiness, technical transfer (TT), and ongoing manufacturing activities related to process analytics (PA) deliverables
• Establishes timelines, plans, and oversees configuration and maintenance of compliant trending and process analytical technology systems
• Develops project plans that integrate with other scheduling functions within the organization and in alignment with program scope
• Escalates risks and tracks milestone progress while ensuring cross functional communication to key stakeholders
• Serves as the subject matter expert (SME) for the development, execution, and maintenance of statistical process control methods and data reporting tools
• Drives the advancement of assigned PA systems focusing on improving scalability and analytical capabilities for drug substance manufacturing
• Documents and reviews process performance and product health through process trending, monitoring, and supporting annual product reviews, manufacturing campaigns summary reports, model validation reports, impact assessments etc.
• Serves as point of contact to customer and internal regulatory team for technical PA aspects of programs
• Develops and manages training content for PA tools
• Trains PA team and coordinates training roll-out for site teams, as required
• Serves as on-call for PA issues and concerns
• Supports role in Good Manufacturing Practices (GMP) environment
• Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Performs advanced process analyses, as required
• Closes deviations and provides a thorough explanation of findings to internal and external stakeholders
• Utilizes new knowledge to promptly drive data-based decisions
• Ensures master batch records (MBRs) and sample plans support PA requirements
• Leads site data stewardship and data governance activities to ensure data and analyses are findable, accessible, interoperable, and reusable to internal and external stakeholders
• Leads informatics, data systems improvement initiatives, and the evaluation of new analytical technologies (e.g., Process Analytical Technologies (PAT), data science tools) and solutions to improve scalability, manufacturability, reliability, yield and cost
• Develops, aligns, and influences best practices for data management and PA across the FDB network, as required
• Serves as a key contributor to the PA strategic roadmap development and owns delivery of assigned items
• Leads stewardship of critical knowledge for PA tools, PAT, and supporting systems
• Writes, reviews, and provides SME feedback for standard operating procedures (SOPs), work instructions, white papers, and other relevant documentation
• Contributes to the external scientific community through presentations, publications, scientific articles and other forms of engagement
• Collaborates with colleagues across Process Science and Manufacturing to design study and/or sampling protocols
• Coordinates the execution of sampling plans for lab and manufacturing runs
• Provides guidance and coaching to junior team members, as needed
• Other duties, as assigned

Knowledge and Skills

• Ability to adapt communication style to differing audiences and advise others on difficult matters
• Advanced problem-solving and project management skills
• Ability to effectively present complex information to others
• Proficient with Snowflake and Python
• Proficient with structured query language (SQL) writing skills
• Ability to provide feedback to others, including leadership
• Strong knowledge of process historians and data management systems (e.g., OSI PI, Statistica, SIMCA)
• Proficient knowledge in Statistical Process Control (SPC) and multivariate data analysis
• Strong knowledge of machine learning techniques, data science techniques, and PAT
• Proficient knowledge of regulatory requirements related to data integrity and PAT
• Knowledge of business acumen and negotiation capabilities
• Ability to integrate and facilitate activities across multiple teams
• Willingness to remain up to date on best practices and industry trends

Basic Requirements

• Bachelor’s degree in Data Science, Biotechnology, or Chemical Engineering with 8 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• Master’s degree with 6 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• PhD with 3 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT)
• Experience working in a GMP environment
• Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
• Experience using Risk Management and RCA tools
• Experience with multivariate modeling and/or PAT application

Preferred Requirements

• Prior biologics drug substance and manufacturing experience, including process development, validation, and transfer
• Experience leading new technology or method implementations and sustainment projects
• Experience authoring CMC sections for regulatory filings and supporting regulatory audits
• Experience transferring and scaling new technologies and/or methods across a manufacturing network
• Experience working with a wide range of data analytics architectures (e.g., warehousing, distributed computing, visualization analytics)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes Ability to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No YesAbility to stand for prolonged periods of time. X No Yes Ability to sit for prolonged periods of time. X No Yes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. X No YesAbility to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

EEO Information

Fujifilm is committed to 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 (FDBN_PNC@fujifilm.com).