Sr. Engineer 1, DPFG MSAT

Position Overview

We are seeking a hands-on, impact-driven DP MSAT Senior Engineer 1 to accelerate our path to operational readiness in a dynamic, start-up environment. This role will lead drug product technical activities from day one, with a primary focus on standing up processes, resolving start-up issues, and supporting client tech transfers into our facility. The ideal candidate brings deep experience in end-to-end tech transfer execution and on-the-floor troubleshooting, with strong competency in automated visual inspection (including recipe creation and qualification), container closure integrity testing (CCIT) qualification, aseptic process simulations (APS/media fills), and filling isolator technologies. You will collaborate cross-functionally with Manufacturing, QA, Engineering, and Clients to rapidly develop, qualify, and optimize processes and equipment, ensuring cGMP compliance and right-first-time delivery. This position requires a proactive self-starter who can operate with minimal direction, make data-driven decisions, and translate ambiguity into executable plans that deliver immediate results.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: ;br>
Job Description

• 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
• Knowledge, Skills, or Abilities:
• Ability to adapt communication style to differing audiences and advise others on complex matters.
• Ability to navigate through crucial conversations.
• Effective communication, both written and oral
• Ability to generate mechanistic and theoretical hypotheses.
• Advanced project management skills
• Ability to effectively present information to others
• Strong strategic thinking skills

Minimum 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:

• Prior Drug Product manufacturing experience
• Experience working in a cGMP environment
• Experience supporting or writing portions of regulatory findings
• Experience qualifying automatic visual inspection equipment
• Experience in CCIT qualification
• Experience with filling isolators
• Experience leading aseptic process simulations
• Experience authoring risk assessments and manufacturing control strategies

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 ().