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.” Help build the digital backbone of next‑generation biopharma. As our System Manager, you will own and elevate core Product Technology platforms—PDLM, ELN, and Risk Management—that power Process Development and MSAT. You’ll translate real-world science into robust, compliant digital solutions, weave data integrity through every workflow, and enable a new, standardized way of working across global teams. If you’re passionate about turning complex requirements into elegant, validated systems—and you thrive in a collaborative, matrixed environment—this role is your opportunity to make a visible impact on tech transfer timelines, batch right‑first‑time performance, and regulatory readiness. Why you’ll love it here Shape how development knowledge (DoE, QbD) flows into manufacturing execution and CPV Own high‑value platforms with direct line of sight to business outcomes Partner across PD, MSAT, Automation/Engineering, QA/Validation, and IT/OT Drive standardization at scale with class‑based, globally reusable configurations Operate with autonomy while influencing best practices across sites What you’ll do Design, configure, implement, and maintain PDLM, ELN, and Risk Management platforms to meet user and compliance requirements Translate business needs into scalable, class‑based configurations and reusable library objects that enable data standardization Ensure cGxP, data integrity (ALCOA), and data security across integrations; partner with QA/CSV on risk‑based validation (GAMP 5, CSA) and audit readiness Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams Deploy class‑based data structures to deliver recipe data models and master data (materials, specs, equipment classes) Develop training, job aids, and adoption materials; coach teams on ISA‑88 and digital recipe best practices Manage external partners and solution vendors; define user requirements, participate in design reviews, and ensure delivery to standards and timelines Contribute to digital thread initiatives linking development knowledge to manufacturing execution and CPV; support regulatory inspections and filings Drive harmonization and standard work across sites (templates, test protocols, UAT scripts) to reduce cycle times and deviations Champion continuous improvement through metrics, KPIs, and standardized ways of working What success looks like Seamless, compliant platforms that accelerate development and tech transfer Standardized data models and libraries that scale globally Strong adoption and user satisfaction through clear training and enablement Audit‑ready documentation and validated configurations Reduced cycle times, deviations, and rework through harmonized processes Minimum Qualification Requirements Bachelors Degree in Engineering or Scientific related field 5 years’ of relevant experience in Information Technology implementing and sustaining GxP impacted systems in life sciences or closely related industries. Demonstrated experience with Computer System Validation (CSV) and data integrity principles (ALCOA). Proven experience with one or more: PDLM/PLM, ELN, or Risk Management Platforms Preferred Requirements Experience in manufacturing or process development systems preferred (MES/LIMS/QMS/data platforms) Preferred experience in pharmaceutical industry, IT CSV Familiarity with ISA-88/ISA-95 standards and digital recipe/data modelling Certifications: GxP/CSV (e.g., ISPE/GAMP), Agile/Scrum, ITIL, PMP/PRINCE2, or data integrity. What you’ll bring Deep understanding of PDLM/PLM and ELN platforms and their application to Process Development/MSAT Strong knowledge of CSV, data integrity (ALCOA), and risk‑based validation (GAMP 5, CSA) Knowledge of ISA‑88/ISA‑95 and digital recipe principles Excellent stakeholder communication and facilitation skills; ability to influence without authority Strong problem‑solving and analytical skills; experience with KPIs and continuous improvement Comfort operating in a global, matrixed environment As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is 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 hiring managers in Europe and the United States. This is a global position that will support all FUJIFILM Biotechnologies 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. At FUJIFILM Biotechnologies, your passion – your Genki – is your power and we empower you to define what Genki means to you. When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer: Competitive salary plus company bonus scheme 35 days of holiday, plus bank holidays. Salary Sacrifice scheme offering, healthcare, bikes, dental etc. Generous pension scheme Free parking and electric charging points Closing date 8th April 2026