Enterprise Recipe Management Lead

** 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:

** 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, Delta

V, 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…