Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB 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 FDB 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.
External USAbout This Role
The Engineer 2, MSAT provides technology transfer support and technical oversight during drug product manufacturing operations.
What You’ll Do
• Leads and supports technology transfer (TT) sub-team activities
• Collaborates and leads execution of sampling protocols, as directed
• Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
• Supports training of manufacturing staff and collaboration with the process sciences group
• Analyzes and summarizes lab data for clients
• Writes process performance qualification (PPQ) protocols and reports
• Interprets and communicates results to the TT team
• 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
• Writes reports and aids in closing out deviations
• Provides process training and consultation on topics related to manufacturing and process
• Provides input to technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Supports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Collaborates with process science global team to develop lab scale protocols.
• Executes and oversees sampling plans for lab runs
• Other duties, as assigne
Basic Requirements
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of relevant work experience (e.g., manufacturing); OR
• Master’s degree with no prior experience
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)
Preferred Requirements
• Experience working in a Good Manufacturing Practices (GMP) environment
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to discern audible cues.
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.
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 place. 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.
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