Computer System Validation Csv Jobs in Cary, NC (NOW HIRING)

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.

• 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

• 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

• 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 Minimum Qualification Requirements
  • Bachelor's 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
  Benefits

  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!

  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).