System Manager, Applications and ELN Administration
NCBiotech, Holly Springs, NC, United States
System Manager, Applications and ELN Administration
Position 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.
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 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
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).
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Position 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.
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 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
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).
#J-18808-Ljbffr