System Manager

Overview 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. Role & Responsibilities: 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.Key ResponsibilitiesShape how development knowledge (DoE, QbD) flows into manufacturing execution and CPVOwn high-value platforms with direct line of sight to business outcomesPartner across PD, MSAT, Automation/Engineering, QA/Validation, and IT/OTDrive standardization at scale with class-based, globally reusable configurationsOperate with autonomy while influencing best practices across sitesWhat you'll doDesign, configure, implement, and maintain PDLM, ELN, and Risk Management platforms to meet user and compliance requirementsTranslate business needs into scalable, class-based configurations and reusable library objects that enable data standardizationEnsure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readinessDefine and enforce standards, templates, libraries, and master data structures in partnership with Master Data teamsDeploy 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 practicesManage external partners and solution vendors; define user requirements, participate in design, A global biopharmaceutical company is seeking a System Manager to oversee Product Technology platforms, including PDLM and ELN. The role emphasizes compliance, data integrity, and the ability to transform complex requirements into effective systems. Prospective candidates..., The Operations Manager will lead the day-to-day running of Tracerco's calibration, technical testing and service operations at our Monitors facilities. The role ensures that radiation monitoring instruments are calibrated, tested and serviced to the highest standards before..., Area Engineering Manager Location: Billingham (Home of McCoy's, Wheat Crunchies, pombear and more...)Work location: On-site, Monday - Friday, 07:30 - 16:00We're looking for an Area Engineering Manager to join us at KP Snacks. If you're ready to bring your ideas to the..., NRL are supporting SeAH Wind on their search for a Production Manager. You will join the team behind the world's largest XXL monopile manufacturing facility in Middlesbrough.SeAH Wind have built the world's largest XXL monopile factory to support the global offshore wind...

reviews, and ensure delivery to standards and timelinesContribute to digital thread initiatives linking development knowledge to manufacturing execution and CPV; support regulatory inspections and filingsDrive harmonization and standard work across sites (templates, test protocols, UAT scripts) to reduce cycle times and deviationsChampion continuous improvement through metrics, KPIs, and standardized ways of workingWhat success looks likeSeamless, compliant platforms that accelerate development and tech transferStandardized data models and libraries that scale globallyStrong adoption and user satisfaction through clear training and enablementAudit-ready documentation and validated configurationsReduced cycle times, deviations, and rework through harmonized processesQualificationsBachelors Degree in Engineering or Scientific related field5+ 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 PlatformsPreferred RequirementsExperience in manufacturing or process development systems preferred (MES/LIMS/QMS/data platforms)Preferred experience in pharmaceutical industry, IT CSVFamiliarity with ISA-88/ISA-95 standards and digital recipe/data modellingCertifications: GxP/CSV (e.g., ISPE/GAMP), Agile/Scrum, ITIL, PMP/PRINCE2, or data integrity.What you'll bringDeep understanding of PDLM/PLM and ELN platforms and their application to Process Development/MSATStrong knowledge of CSV, data integrity (ALCOA+), and risk-based validation (GAMP 5, CSA)Knowledge of ISA-88/ISA-95 and digital recipe principlesExcellent stakeholder communication and facilitation skills; ability to influence without authorityStrong problem-solving and analytical skills; experience with KPIs and continuous improvementComfort operating in a global, matrixed environmentAbout Us 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".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 ongoing development training. In addition to this, we offer:BenefitsCompetitive salary plus company bonus scheme35 days of holiday, plus bank holidays.Salary Sacrifice scheme offering, healthcare, bikes, dental etc.Generous pension schemeFree parking and electric charging points#J-18808-Ljbffr Similar jobs

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