Sr. Engineer 1, DPFG MSAT

Fujifilm•Holly Springs, NC

About The Position

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.

Requirements

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
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)

Nice To Haves

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

Responsibilities

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