Sr. Engineer 1, DPFG MSAT

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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:

Bachelors degree in in Engineering Life Science or Chemical Engineering with 8 years of relevant experience (e.g. manufacturing); OR
Masters 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 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.

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 ().

Required Experience:

Senior IC

Position OverviewWe 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 is...