Computer System Validation Jobs in Raleigh, NC (NOW HIRING)

Position Overview

Help build the digital backbone of nextgeneration 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.

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

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 rightfirsttime performance, and regulatory readiness.

Why you'll love it here

• Shape how development knowledge (DoE, QbD) flows into manufacturing execution and CPV
• Own highvalue 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 classbased, 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, classbased configurations and reusable library objects that enable data standardization
• Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on riskbased validation (GAMP 5, CSA) and audit readiness
• Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams
• Deploy classbased data structures to deliver recipe data models and master data (materials, specs, equipment classes)
• Develop training, job aids, and adoption materials; coach teams on ISA88 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
• Auditready 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 riskbased validation (GAMP 5, CSA)
• Knowledge of ISA88/ISA95 and digital recipe principles
• Excellent stakeholder communication and facilitation skills; ability to influence without authority
• Strong problemsolving and analytical skills; experience with KPIs and continuous improvement
• Comfort operating in a global, matrixed environment

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 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.

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).

Employment Type: OTHER