Sr. Engineer 1, MSAT

Overview:

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 US:

About This Role

The Sr. Engineer 1, MSAT serves as a subject matter expert and provides technology transfer support and technical oversight during manufacturing operations.

What You'll Do

• Develops and implements training for drug product manufacturing staff on new processes and procedures

• Develops, implements, and leads training for drug product group on new procedures, the use of equipment in the MSAT lab

• Leads troubleshooting and process impact assessments

• Designs, implements, and analyzes lab data aimed at solving complex manufacturing problems

• Provides interpretation of manufacturing data, analyze lab or manufacturing data to solve manufacturing problems

• Leads execution of all aspects of process validation including ancillary process validation (small-scale studies), protocols and reports

• Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects

• Provides engineering and scientific leadership to support clinical and commercial processes

• Participate in process sub-teams throughout the phases of technology transfer (TT)

• Serves as subject matter expert (SME) to support TT stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes

• Provides comprehensive written manufacturing protocols and reports summarizing investigations, studies and projects.

• Develops process validation strategy and oversees execution of manufacturing process validation runs

• Leads generation of sampling plans for process validation reports (PVRs) and investigations

• Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)

• As technical SME supports generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies

• Generates and executes process training and consults on topics related to manufacturing and process

• Leads technical risk assessments for new manufacturing processes

• Oversees process monitoring and overall management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification

• Writes and reviews documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocols and reports, impact assessments, etc.

• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support

• Leads continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost

• Deploys and maintains Large Scale strategic roadmap for continuous and breakthrough improvements, and associated requirements

• As technical SME provides supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions

• Perform other duties, as assigned

Basic Requirements

• Bachelor's degree in in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g., manufacturing); OR

• Master's degree with 6 years of experience; OR

• PhD with 4 years of experience• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment.

• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting

• Experience supporting or writing portions of regulatory findings

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 .

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.