Sr Engineer II Process Analytics

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.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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 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 teams
  Oversees the development and rollout 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 databased decisions
• Ensures master batch records (MBRs) and sample plans support PA requirements
• Negotiates with crossfunctional 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 problemsolving 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

• Bachelors degree in Data Science Biotechnology or Chemical Engineering with 12 years of relevant experience (e.g. data
  engineering manufacturing bioprocess development PAT); or
• Masters 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 crossfunctional teams

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No Yes
May 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 Yes
Ability 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 Yes
Ability 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 Yes
Ability to operate machinery and/or power tools. X No Yes
Ability 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

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.

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