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 OverviewFollow 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) deliverablesEstablishes timelines, plans, and oversees configuration and maintenance of compliant trending and process analytical technology systemsDevelops project plans that integrate with other scheduling functions within the organization and in alignment with program scopeEscalates risks and tracks milestone progress while ensuring cross functional communication to key stakeholdersServes as the subject matter expert (SME) for the development, execution, and maintenance of statistical process control methods and data reporting toolsDrives the advancement of assigned PA systems focusing on improving scalability and analytical capabilities for drug substance manufacturingDocuments 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 programsDevelops and manages training content for PA toolsTrains PA team and coordinates training roll-out for site teams, as requiredServes as on-call for PA issues and concernsSupports role in Good Manufacturing Practices (GMP) environmentServes 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 deviationsPerforms advanced process analyses, as requiredCloses deviations and provides a thorough explanation of findings to internal and external stakeholdersUtilizes new knowledge to promptly drive data-based decisionsEnsures master batch records (MBRs) and sample plans support PA requirementsLeads site data stewardship and data governance activities to ensure data and analyses are findable, accessible, interoperable, and reusable to internal and external stakeholdersLeads 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 costDevelops, aligns, and influences best practices for data management and PA across the FDB network, as requiredServes as a key contributor to the PA strategic roadmap development and owns delivery of assigned itemsLeads stewardship of critical knowledge for PA tools, PAT, and supporting systemsWrites, reviews, and provides SME feedback for standard operating procedures (SOPs), work instructions, white papers, and other relevant documentationContributes to the external scientific community through presentations, publications, scientific articles and other forms of engagementCollaborates with colleagues across Process Science and Manufacturing to design study and/or sampling protocolsCoordinates the execution of sampling plans for lab and manufacturing runs Provides guidance and coaching to junior team members, as neededOther duties, as assignedKnowledge and Skills
Ability to adapt communication style to differing audiences and advise others on difficult mattersAdvanced problem-solving and project management skillsAbility to effectively present complex information to othersProficient with Snowflake and Python Proficient with structured query language (SQL) writing skillsAbility to provide feedback to others, including leadershipStrong knowledge of process historians and data management systems (e.g., OSI PI, Statistica, SIMCA)Proficient knowledge in Statistical Process Control (SPC) and multivariate data analysisStrong knowledge of machine learning techniques, data science techniques, and PATProficient knowledge of regulatory requirements related to data integrity and PATKnowledge of business acumen and negotiation capabilitiesAbility to integrate and facilitate activities across multiple teamsWillingness to remain up to date on best practices and industry trendsBasic Requirements
Bachelor’s degree in Data Science, Biotechnology, or Chemical Engineering with 8 years of relevant experience (e.g., dataengineering, manufacturing, bioprocess development, PAT); orMaster’s degree with 6 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); orPhD with 3 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT)Experience working in a GMP environmentExperience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)Experience using Risk Management and RCA toolsExperience with multivariate modeling and/or PAT application
Preferred Requirements
Prior biologics drug substance and manufacturing experience, including process development, validation, and transferExperience leading new technology or method implementations and sustainment projectsExperience authoring CMC sections for regulatory filings and supporting regulatory auditsExperience transferring and scaling new technologies and/or methods across a manufacturing networkExperience 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 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 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 InformationIf 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).
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