This role partners with QC, QA/CSV, Validation, Global IT, Cybersecurity, Manufacturing, and ... Bachelor's degree in Computer Science, Information Systems, Engineering, or related field required.
This role partners with QC, QA/CSV, Validation, Global IT, Cybersecurity, Manufacturing, and ... Bachelor's degree in Computer Science, Information Systems, Engineering, or related field required.
Acting as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance ... Doctorate degree OR Master's degree and 2 years of Information Systems or Engineering experience OR ...
Acting as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance ... Doctorate degree OR Master's degree and 2 years of Information Systems or Engineering experience OR ...
Acting as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance ... Doctorate degree OR Master's degree and 2 years of Information Systems or Engineering experience OR ...
Acting as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance ... Doctorate degree OR Master's degree and 2 years of Information Systems or Engineering experience OR ...
HCIT Application Integration Developer
Garner, NC · On-site +1
$44.75 - $59.50/hr
HCIT Application Integration Developer (Remote) Position Summary: The Application Integration ... Transform messaging protocols (e.g., CSV to HL7, HL7 to FHIR/JSON/XML) * Ensure end-to-end message ...
HCIT Application Integration Developer
Garner, NC · On-site +1
$44.75 - $59.50/hr
HCIT Application Integration Developer (Remote) Position Summary: The Application Integration ... Transform messaging protocols (e.g., CSV to HL7, HL7 to FHIR/JSON/XML) * Ensure end-to-end message ...
Job title QLIKVIEW & QLIKSENSE DEVELOPER 2.Job summary 1. Develop the backend code for QlikView ... text files csv) then perform transformation and Load the data with maximum optimization into ...
Job title QLIKVIEW & QLIKSENSE DEVELOPER 2.Job summary 1. Develop the backend code for QlikView ... text files csv) then perform transformation and Load the data with maximum optimization into ...
HCIT Application Integration Developer
Garner, NC · On-site +1
$90K - $110K/yr
HCIT Application Integration Developer (Remote) Position Summary: The Application Integration ... Transform messaging protocols (e.g., CSV to HL7, HL7 to FHIR/JSON/XML) * Ensure end-to-end message ...
HCIT Application Integration Developer
Garner, NC · On-site +1
$90K - $110K/yr
HCIT Application Integration Developer (Remote) Position Summary: The Application Integration ... Transform messaging protocols (e.g., CSV to HL7, HL7 to FHIR/JSON/XML) * Ensure end-to-end message ...
VALIDATION ENGINEER Location: Raleigh, NC (AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY ... Requirements * 3+ years of Computer System Validation (CSV) experience with process control, SCADA ...
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VALIDATION ENGINEER Location: Raleigh, NC (AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY ... Requirements * 3+ years of Computer System Validation (CSV) experience with process control, SCADA ...
Ensure all systems are delivered in accordance with GMP, CSV, and Data Integrity requirements ... Education: Bachelor's degree in Engineering, Computer Science, or Life Sciences required Master ...
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Ensure all systems are delivered in accordance with GMP, CSV, and Data Integrity requirements ... Education: Bachelor's degree in Engineering, Computer Science, or Life Sciences required Master ...
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
QA Consultant
Holly Springs, NC · Remote
Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred * 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or ...
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QA Consultant
Holly Springs, NC · Remote
Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred * 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or ...
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Senior MES Solution Architect
Durham, NC · On-site
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Senior MES Solution Architect
Durham, NC · On-site
Mentor engineers and operations teams; create reusable playbooks, standards, and knowledge assets ... Hands-on with GxP/CSV or CSA, data integrity, and OT security concepts (zones/conduits, defense-in ...
Sales Engineer
Chapel Hill, NC · On-site
Experience with API Integrations and CSV file manipulation
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Sales Engineer
Chapel Hill, NC · On-site
Experience with API Integrations and CSV file manipulation
Boomi Consultant
Raleigh, NC · On-site
... CSV, Fixed width) integration, Groovy/JavaScript, and relational/NoSQL databases • Knowledge of Agile, DevOps, CI/CD, and API lifecycle management • Ability to work in a global delivery model ...
Boomi Consultant
Raleigh, NC · On-site
... CSV, Fixed width) integration, Groovy/JavaScript, and relational/NoSQL databases • Knowledge of Agile, DevOps, CI/CD, and API lifecycle management • Ability to work in a global delivery model ...
... csv, SOAP, HL7, etc.) in Rhapsody with Symphonia and Javascript (ECMA/E4X) • Formatting data into Conduent Maven Integration Format (MIF) for import into the Disease Surveillance System • Utilize ...
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... csv, SOAP, HL7, etc.) in Rhapsody with Symphonia and Javascript (ECMA/E4X) • Formatting data into Conduent Maven Integration Format (MIF) for import into the Disease Surveillance System • Utilize ...
... csv, SOAP, HL7, etc.) in Rhapsody with Symphonia and Javascript (ECMA/E4X) • Formatting data into Conduent Maven Integration Format (MIF) for import into the Disease Surveillance System • Utilize ...
Quick apply
... csv, SOAP, HL7, etc.) in Rhapsody with Symphonia and Javascript (ECMA/E4X) • Formatting data into Conduent Maven Integration Format (MIF) for import into the Disease Surveillance System • Utilize ...
... QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness • Implement RBAC/least ... Required : • Bachelors Degree in Computer Science, Engineering or Scientific related field • 5+ ...
New
... QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness • Implement RBAC/least ... Required : • Bachelors Degree in Computer Science, Engineering or Scientific related field • 5+ ...
New
The Team AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and ... Basic knowledge of messaging formats used in healthcare integration (HL7, EDI, CSV, XML, etc.
The Team AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and ... Basic knowledge of messaging formats used in healthcare integration (HL7, EDI, CSV, XML, etc.
The Team AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and ... Basic knowledge of messaging formats used in healthcare integration (HL7, EDI, CSV, XML, etc.
The Team AI & Engineering leverages cutting-edge engineering capabilities to build, deploy, and ... Basic knowledge of messaging formats used in healthcare integration (HL7, EDI, CSV, XML, etc.
Csv Engineer information
See Raleigh, NC salary details
$35.2K - $44.2K
5% of jobs
$44.2K - $53.2K
3% of jobs
$53.2K - $62.2K
5% of jobs
$62.2K - $71.2K
9% of jobs
$75.8K is the 25th percentile. Wages below this are outliers.
$71.2K - $80.3K
5% of jobs
$80.3K - $89.3K
7% of jobs
The median wage is $97.7K / yr.
$89.3K - $98.3K
16% of jobs
$98.3K - $107.3K
4% of jobs
$113.3K is the 75th percentile. Wages above this are outliers.
$107.3K - $116.3K
30% of jobs
$116.3K - $125.3K
2% of jobs
$125.3K - $134.4K
13% of jobs
$35.2K
$97.1K
$134.4K
How much do csv engineer jobs pay per year?
What engineers make $500,000?
What is a CSV Engineer job?
A CSV (Computer System Validation) Engineer is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, comply with regulatory requirements. They develop validation protocols, perform testing, document results, and ensure adherence to industry standards like FDA 21 CFR Part 11 and GAMP 5. Their goal is to confirm that software and hardware systems function correctly, maintain data integrity, and meet compliance requirements.
What does a CSV engineer do?
What are the common challenges faced by a CSV Engineer in the pharmaceutical or medical device industry?
CSV Engineers in the pharmaceutical or medical device industry often face the challenge of keeping up with evolving regulatory requirements and ensuring all computerized systems remain compliant throughout their lifecycle. Managing comprehensive documentation, coordinating with multiple departments, and troubleshooting complex system changes can add to the workload. Successful CSV Engineers are proactive about staying informed of regulatory updates, are highly organized, and collaborate closely with Quality Assurance, IT, and operations teams. This dynamic environment offers the opportunity to learn continuously, develop expertise in validation best practices, and advance into leadership or specialized quality roles.
How much do CSV engineers make in the US?
What is the salary of a CSV engineer?
What are the key skills and qualifications needed to thrive in the Csv Engineer position, and why are they important?
To thrive as a CSV Engineer (Computer System Validation Engineer), you need a solid understanding of validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or information technology. Familiarity with validation lifecycle documentation, risk assessment tools, and industry-standard systems like SAP, LIMS, and TrackWise is highly valued, as are certifications such as GAMP or Six Sigma. Strong attention to detail, analytical thinking, and excellent communication skills help CSV Engineers collaborate efficiently with cross-functional teams and ensure thorough documentation. These skills are crucial to guarantee that computerized systems in regulated industries meet compliance requirements, supporting product quality and patient safety.
Other
This job post has expired today. Applications are no longer accepted.
Fujifilm rating
8.3
Based on 66 frontline employees who took The Breakroom Quiz
46th of 518 rated manufacturers
Job description
The Principal QC IT System Analyst is is a senior professional who works independently with minimal guidance, acts as a resource for colleagues, and may lead small-to-medium projects or processes. The role ensures reliable, secure, and compliant operation of QC informatics applications (primarily LabWare LIMS and Waters Empower) and related integrations across the lifecycle. This role partners with QC, QA/CSV, Validation, Global IT, Cybersecurity, Manufacturing, and vendors to plan and execute changes, maintain validated state (GxP/CSV), and drive continuous improvement that enhances QC throughput, data integrity (ALCOA+), and inspection readiness. The incumbent solves complex problems by taking a new perspective on existing solutions and uses judgment based on the analysis of multiple sources of information in alignment with FUJIFILM Biotechnologies Global standards and procedures.
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
What You'll Do
- Service Delivery and Tier-2/3 Support: Delivers timely, expert support for LIMS/Empower and related QC applications; monitors SLAs, trends incidents/problems, and implements corrective and preventive actions to sustain operations.
- System Reliability, Availability, and Security: Administers user/role management, configurations, patching, backups, archiving, license management, and integrations; partners with Cybersecurity/Global IT to address vulnerabilities and risks.
- ITSM/ITIL Execution and Process Improvement: Executes and refines incident, problem, change, configuration, and release processes; authors/updates SOPs and work instructions to improve efficiency, stability, and compliance.
- GxP Compliance, CSV, and Documentation: Authors/reviews/approves risk assessments, validation plans/protocols/reports, and IT QMS documentation; maintains validated state per cGMP, 21 CFR Part 11, EU Annex 11, Annex 15, GAMP 5.
- Project and Enhancement Delivery: Plans and leads small-to-medium upgrades, enhancements, and integrations; manages scope, schedule, budget, and quality; applies risk-based validation and robust change control.
- Vendor and Service Provider Management: Serves as primary site liaison with LabWare and Waters; negotiates priorities and deliverables, drives root-cause resolution, and ensures contracted value and compliance outcomes.
- Work Direction and Mentoring: Provides day-to-day guidance and work direction to up to 3 analysts/administrators; mentors colleagues, coordinates workload, and contributes input to performance discussions per FUJIFILM Biotechnologies Global expectations.
- Continuous Improvement and Standardization: Simplifies and standardizes procedures, dashboards, and metrics; champions data lifecycle controls and data integrity; identifies automation opportunities across workflows.
- Metrics, Reporting, and Inspection Readiness: Defines and reports KPIs (e.g., uptime, incident backlog, change success rate, validation cycle times); prepares audit/inspection evidence and provides authoritative system responses.
- Stakeholder Engagement and Communication: Communicates plans, risks, cutover strategies, and impacts to QC leadership and cross-functional partners; aligns release schedules to minimize disruption.
Minimum Qualifications
- Bachelor's degree in Computer Science, Information Systems, Engineering, or related field required.
- Advanced degree (MS/MEng) preferred.
- An equivalent combination of education and relevant experience may be considered per FUJIFILM Biotechnologies Global guidelines.
Preferred Qualifications
- 12+ years of progressive IT experience, including 5+ years supporting GxP-regulated systems in pharmaceutical/biologics environments.
- 3+ years hands-on administration with LabWare LIMS and 3+ years with Waters Empower (e.g., configuration, upgrades/patching, user/role administration, integrations, license management).
- 3+ years leading small-to-medium projects or workstreams with scope/schedule/budget accountability, applying risk-based CSV and change control.
- Demonstrated audit/inspection support experience and strong familiarity with ITIL/ITSM processes.
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).
About Fujifilm
Sourced by ZipRecruiter
With each Industry we enter, We’ve learned to Leverage and Adapt our knowledge, Expertise and rRsources to make the World a better place. When it comes to Innovating for a Healthier World and a more sustainable society, we’ll NEVER STOP. Fujifilm will contribute to the social challenges by creating new value in a wide range of business domains through innovation in Products, Services, and Technological Development. We launched our Healthcare Business with X-ray film in 1936. And now, We are developing our business in areas of prevention, diagnosis, and treatment as a Comprehensive Healthcare Company. We will never stop Innovating for a Healthier World.
Industry
Chemical manufacturing
Company size
10,000+ Employees
Headquarters location
Minato-ku, Tokyo, JP