**Position Overview** The Digital Recipe Lead drives the digital transformation of technology transfer by defining and operationalizing end-to-end digital recipe management across the development-to-commercial continuum. Partnering with Process Development, MSAT, Automation/Engineering, QA/Validation, and IT/OT, this role standardizes and modularizes process knowledge in PDLM systems aligned to ISA-88/ISA-95 to enable rapid, compliant deployment to MES/DCS/SCADA platforms. **Company Overview** The work we do at FUJIFILM Biotechnologies 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 FUJIFILM Biotechnologies and help make 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. 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: https://www.fujifilm.com/us/en/about/region/careers **Job Description** The role ensures data integrity, cGxP compliance, and robust governance for digital recipes, accelerating tech transfer, improving right-first-time execution, and sustaining lifecycle recipe management globally. Operates with minimal guidance and influences cross-functional stakeholders to establish enterprise standards and reusable libraries. What you'll do: + Translate, author, modularize, and standardize digital recipes aligned to ISA-88/ISA-95 for upstream, downstream, and support unit operations; create reusable equipment-independent modules and parameter sets to accelerate multi-site tech transfer. + Build and curate a governed enterprise recipe library within PDLM (e.g., DTLS, QbDVision), including versioning, traceability, and linkage to process parameters, CPPs/CMAs, and control strategies. + Translate process knowledge from PD/Client partners into structured master recipes and functionally-tested procedures ready for deployment to MES/DCS (e.g., Syncade, PAS-X, DeltaV, Rockwell), coordinating mapping to equipment models and master data. + Define and implement governance (RACI, SOPs, WI, SLAs) for end-to-end digital recipe lifecycle: authoring, review/approval, change control, deployment, and retirement across sites and products. + Ensure cGxP, data integrity (ALCOA+), and data security requirements across integration between PDLM and other technology layers; partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness. + Define recipe data models, parameter ontologies, and naming conventions; steward reference data/master data (materials, specs, equipment classes) with Master Data teams to ensure interoperability and scalability. + Drive harmonization and standard work across sites (templates, libraries, test protocols, UAT scripts) to reduce cycle times and deviations. + Support change management and training for business adoption (author/operator training, guidance, job aids); coach teams on interpreting and applying ISA-88 and digital recipe best practices. + Manage external partners and solution vendors for PDLM capabilities; define user requirements, participate in design reviews, and ensure delivery to standards and timelines. + Contribute to digital thread initiatives linking development knowledge (DoE, QbD) to manufacturing execution and CPV; support readiness for regulatory inspections and filings. + And other dutes as assigned from time to time. Minimum Requirements: + Bachelors Degree in Engineering or Scientific related field + 8+ years’ of relevant experience in biopharmaceutical/biotech manufacturing, MSAT, process development. + Minimum of 1 year developing processes or recipes utilizing S88 standard + Minimum of 2 years in tech transfer + Any combination of education and experience, which would provide an equivalent background to deliver against role expectations. Preferred Requirements: + Experience with PDLM software such as DTLS or QbD Vision + Experience establishing enterprise recipe standards/libraries across multi-site networks. + Familiarity with integration architectures (ISA-95 layers, OPC UA, PI/Historians, middleware), cybersecurity practices (ISA/IEC 62443), and data models/ontologies for manufacturing. + Exposure to PAT, MVDA, and CPV integration into recipe/control strategies. Knowledge, Skills and Abilities: + This role should understand PDLM applications but also Process Development and MSAT functions. They should have a strong process development or manufacturing background. They will need to be experienced in regulatory documents such as filings or APQR. + Advanced knowledge of ISA-88/ISA-95, PDLM/MES/DCS ecosystems, and GMP manufacturing processes (upstream/downstream, buffer/media). + Strong grasp of QbD concepts, CPP/CQA mapping, and control strategy translation into executable recipes. + Ability to define URS/FRS and support testing (IQ/OQ/PQ, UAT). + Ability to architect scalable data/metadata structures for recipes and master data. + Excellent stakeholder management, communication, and change leadership; capable of leading cross-functional teams through ambiguity. + Analytical problem-solving with bias for action; able to handle multiple concurrent transfers and sites. The US salary range for this position is $120,000 to $198,000. Pay within this range varies by work location and may also depend on job-related knowledge, skills, and experience. Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental,vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k)savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time,and company holidays. Explore a supportive environment that enriches both your personal and professional growth! As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personaldata relating to job applicants. The organizationis committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiringmanagers in Europe and the United States. This is a global position that will support all our sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site. 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. **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 (fdbglobaltalent@fujifilm.com). **Job Locations** _US-Remote_ **Posted Date** _16 hours ago_ _(2/20/2026 7:06 AM)_ **_Requisition ID_** _2026-36916_ **_Category_** _Information Technology_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_