Sr. Engineer II, Process Analytics

Position Overview

The Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, technical oversight, and strategic input across laboratory and manufacturing operations. This role leads junior team members through all aspects of process analytic (PA) activities and provides technical guidance and coaching.

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

• Provides oversight on all aspects of site readiness, technology transfer (TT) programs, and ongoing manufacturing activities related to process analytics (PA) deliverables
• Establishes and ensures timelines and plans align with relevant stakeholders and that deliverables are successfully completed on time
• Ensures team project plans are integrated 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
• Provides oversight on the execution and advancement of process trends and process verification plans
• Serves as the point of contact to customer and internal regulatory team for technical aspects of the process and program
• Facilitates delivery of documentation for internal and external use, such as comprehensive written manufacturing protocols and reports summarizing investigations, studies, and projects
• Serves as the subject matter expert (SME) while leading and conducting troubleshooting, process impact assessments, and executing root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Manages Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, including coordination and input to customer regulatory filings
• Identifies training needs and facilitates training for laboratory and manufacturing teamsOversees the development and roll-out of training content related to PA tools
• Supports role in Good Manufacturing Practices (GMP) environment
• Leads the technical team with investigating project challenges through risk assessment tools and techniques, as needed
• 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
• Negotiates with cross-functional stakeholders
• Oversees data stewardship and data governance activities, including alignment with global FDB network
• Ensures data and analyses are findable, accessible, interoperable, and reusable to internal and external stakeholders
• Leads best practices for TT and process performance qualification (PPQ) strategies globally, as required
• Oversees informatics and data systems improvement initiatives to improve scalability, manufacturability, reliability, yield and cost
• Serves as a key contributor to the PA strategic roadmap development and owns delivery of assigned items
• Communicates and aligns roadmap elements with internal and external stakeholders, as directed
• Oversees the evaluation of new analytical technologies (e.g., Process Analytical Technologies (PAT), Data Science tools) and the development of new solutions
• Provides guidance on implementation and sustainment strategies
• Oversees 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
• Routinely represents FDB at technical conferences, seminars, etc. and engages the biotechnology community
• Remains up to date on best practices and industry trends and ensures PA team is aware
• Develops presentations, publications, scientific articles, and other materials for external engagement with the external scientific community
• Facilitates the design of study and/or sampling protocols by ensuring the PA and Manufacturing teams provide input and review
• Mentors junior team members, lab, and manufacturing colleagues
• 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
• Ability to develop effective working relationships internally and externally
• Proficient with Snowflake and Python
• Proficient with structured query language (SQL) writing skills
• 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, and PAT
• Proficient knowledge of regulatory requirements related to data integrity and PAT
• Intermediate knowledge of business acumen, negotiation tactics, and ability to build business cases
• Proficient ability to integrate and facilitate activities across multiple teams
• Ability to remain up to date on best practices and industry trends

Basic Requirements

• Bachelor’s degree in Data Science, Biotechnology, or Chemical Engineering with 12 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• Master’s degree with 8 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• PhD with 5 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
• Prior experience leading new technology or method implementations and sustainment projects

Preferred Requirements

• Prior biologics drug substance and manufacturing experience, including process development, validation, and transfer
• 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)
• Experience leading and influencing cross-functional teams

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).