IT CSV Analyst
Katalyst Healthcares and Life Sciences
Job Description:
We are seeking a detail-oriented and experienced IT CSV Analyst to support the validation of computerized systems in compliance with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other GxP standards. The role involves developing, executing, and maintaining validation documentation to ensure that systems are fit for intended use and compliant with quality standards.
Responsibilities:
We are seeking a detail-oriented and experienced IT CSV Analyst to support the validation of computerized systems in compliance with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other GxP standards. The role involves developing, executing, and maintaining validation documentation to ensure that systems are fit for intended use and compliant with quality standards.
Responsibilities:
- Develop and maintain Computer System Validation (CSV) documentation including:
- Validation Plans (VP).
- User Requirements Specifications (URS).
- Functional Specifications (FS).
- Risk Assessments.
- Test Plans, IQ/OQ/PQ Protocols.
- Traceability Matrices.
- Validation Summary Reports (VSR).
- Work closely with IT, QA, business stakeholders, and vendors to ensure compliance with regulatory and internal requirements.
- Review and assess change controls, deviations, and CAPAs related to computerized systems.
- Ensure systems are developed and maintained in accordance with GAMP 5 guidelines.
- Support audits and inspections by regulatory authorities and clients.
- Participating in system implementation projects, ensuring validation activities are integrated into the project lifecycle.
- Maintain documentation and validation lifecycle in alignment with data integrity principles (ALCOA+).
- Conduct periodic reviews of validated systems to ensure ongoing compliance.
- Bachelor's degree in computer science, Information Technology, Life Sciences, or related field.
- Minimum 3-5 years of experience in IT CSV, QA, or compliance roles in a regulated environment (pharma, biotech, or medical devices).
- Strong knowledge of GxP regulations, including 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Familiarity with SDLC (Software Development Life Cycle) and validation in Agile/Waterfall methodologies.
- Experience with ERP, LIMS, MES, Track Wise, or other GxP-regulated systems is a plus.
- Strong documentation, analytical, and communication skills.
- Ability to work independently and in cross-functional teams.
- Experience with validation tools or eQMS systems (e.g., Veeva, Master Control, Kneat).
- Knowledge of cloud-based validation and SaaS compliance.
- Understanding data integrity and cybersecurity principles in a regulated environment.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the IT CSV Analyst in United States vacancy
- ...CREO Senior Analyst Senior Analysts in IT Compliance and Quality take on a proactive, hands-on role collaborating with senior staff to help clients... ...-quality, client-ready Computerized System Validation (CSV) deliverables. Experience with GMP / Supply Chain Management...SuggestedWork experience placementRemote work
Creo
United States1 day ago - IT CSV Analyst needs 5+ years of experience working with Computer System Validations in a GMP pharmaceutical environment. IT CSV Analyst requires: Bachelors degree in Software Engineering, Computer Science, Computer Engineering, or a related field . Minimum of 5+ years...SuggestedLocal area
- Creo Inc is looking for a Senior Analyst in IT Compliance and Quality based in North Carolina. The role focuses on managing IT compliance projects, delivering client-focused solutions, and enhancing regulatory compliance within the life sciences industry. Candidates should...Suggested
$81 - $91.24 per hour
...We’re Hiring: Senior IT Analyst (GxP & Infrastructure) Location: Foster City, CA (Hybrid — Local Candidates Only) Pay Range: $81.00... ...Analyst to lead system administration, computer system validation (CSV), and operational support within our life sciences environment....SuggestedFull timeContract workLocal areaATR International
Foster, CA10 hours ago- ...Site Sr IT Analyst – Manufacturing Operations At Elanco – it all starts with animals! As a global leader in animal health, we are dedicated... ..., and data flows. Knowledge of computer system validation (CSV), CAPA, and documentation practices within GxP environments....SuggestedSummer workLocal areaRelocation
Elanco Animal Health
Wathena, KS1 day ago $94k - $151.8k
...data driven decision support across Computer Systems Validation (CSV) processes. The Digital Enablement Lead identifies and... ...equivalent practical experience. ~2+ years in roles such as business analyst, data analyst, quality analyst, QMS analyst, or CSV lead. ~5+...Immediate startJ&J Family of Companies
Raritan, NJ7 days ago- ...Position- Sr. Analyst II Hybrid Position - Foster City - Local Candidates Duration: 6 Months... ...Lead and execute validation activities (CSV lifecycle), including protocol authoring,... ...platforms (AWS/Azure) and enterprise IT environments ~ Hands-on experience with...Contract workLocal area
I.T. Solutions, Inc.
Foster, CA10 hours ago $60 - $65 per hour
...data conversion, data migration, and data mapping. Strong expertise in multiple data formats, including Oracle, SQL, MySQL, Flat Files (CSV, XML, etc.). Hands-on experience with ETL tools such as SSIS and Talend. Strong problem-solving, analytical, and communication skills...Local areaRemote workJobot
Shreveport, LA5 days ago$43.89k - $85.07k
...community at a time. Position Summary The Member Data Transition Analyst is responsible for accurately loading, processing, requesting,... ...Preferred Qualifications Familiarity with file formats such as CSV, Excel, and fixed‑width files Proficiency in Microsoft Access Basic...Hourly payFull timeTemporary workLocal areaRemote workEffizotech
Pflugerville, TX5 days ago$40 - $44 per hour
...technical specifications; provide solutions design, build, and deploy IT solutions and services; provide maintenance and support. Act as... ...Strong background in GMP, GAMP, and Computer System Validation (CSV). Hands‑on experience supporting MES/LES platforms in production...Full timeLocal areaShift work$20 - $25 per hour
...Residential Data Analyst Intern Voltus is hiring a Residential Data Analyst Intern to help our Partnerships team make sense of the sprawling... ...more importantly, you're the kind of person who, when handed a CSV from one portal and an API response from another, immediately...Hourly payInternshipImmediate startVoltus Inc
United States1 day ago- ...This person will be doing all the daily data analyst skills for the Utilities team. They will be working on one main projects which is... ...acceptance system, list of defects on assests, generating locally store CSV file (generating PDF document), creating a database that will...Internship
Insight Global
Orlando, FL3 days ago $90k - $100k
...Learning Solutions Data Systems IT Solutions Financial Solutions Equity... ...data delivery needs. The Data Integration Analyst works as part of a fast-paced, deadline-driven... ...~ Experience working with data files (CSV, Excel) and file transfer methods (e.g., SFTP...For contractorsH1bWork at officeLocal areaRemote workNight shiftPublic Consulting Group
Montgomery, AL2 days ago- ...Data Analyst Internship (Revenue Cycle & Analytics) Chicago, Illinois, United States About AAC Ambulatory Anesthesia Care (AAC... ...reimbursement trends Clean, validate, and organize datasets (Excel, CSV, internal systems) Identify trends, gaps, and opportunities...InternshipWork at officeFlexible hours
Mobile Anesthesiologists
Chicago, IL2 days ago - ...goals, BHJD has developed the position of Data and Information Analyst. In this position, the Analyst will be responsible for researching... ...acquiring and using data in various formats (JSON, XML, CSV, Excel, etc.) from various sources (APIs, files downloaded from...
PMHCC
Philadelphia, PA5 days ago - RD Labs IT Senior Analyst page is loaded## RD Labs IT Senior Analystlocations: Indianapolis, INtime type: Full timeposted on: Posted Todayjob... ...Business Analyst.● Experience with Computer System Validation (CSV) and ITIL management tools like ServiceNow.● Strong understanding...Summer workLocal areaRelocationFlexible hours
$60k - $75k
...Company Description Junior Data Analyst (Operations / Sales Analytics) Location: Cerritos Employment Type: Full-time, On-site... ...data from systems such as Salesforce, Shopify, QuickBooks, and CSV files Build and maintain KPI dashboards and recurring reports...Full timeSBT Global, Inc.
Cerritos, CA4 days ago- ...Position - Data Governance Analyst Location - Phoenix AZ (Hybrid) Start Date -... ...experience with data analysis specifically as it relates to enterprise data management... ...experience using common file formats such as CSV, TEXT, JSON, XML, XSD, etc. Excellent...Contract workImmediate start
Georgia IT Inc
Phoenix, AZ6 days ago - ...Data Analyst Location: Albany, NY 12229 Duration: 2- 3 years Contract Position... ...in flat-file data sources including text/csv AND JSON ~60 months' experience months... ...years of diversified experience in providing IT Consulting Services, Artificial Intelligence...Contract work
InterSources
Albany, NY3 days ago - ...The Data Integration Analyst I is responsible for supporting the transformation, configuration, and ingestion of client data files within... ...Strong understanding of file formats and transformation logic (CSV, fixed-width, XML, JSON). ~ Experience troubleshooting ingestion...Contract work
Allied Solutions
Carmel, IN1 day ago - ...Information Technology Analyst II - GIS The Department of Information Technology, GIS Division, is seeking an Information Technology... ...file and enterprise geodatabases (SDE), shapefiles, REST services, CSV/JSON imports, attribute schema design. Comfort with scripting...Full timeContract workPart timeWork at officeLocal areaMonday to Friday
GovernmentJobs.com
Fairfield, CA2 days ago - ...in key regions throughout the world. Manufacturing Data Analyst (Data Tech) Role Summary We are seeking a... ...reporting exports. Parse and clean "messy" data from flat files (CSV, XML, JSON) and MES databases. Performance Metrics & Statistical...Local area
Sanmina-SCI
Carrollton, TX2 days ago - ...Data Analyst Position The people here at the company don't just create products — they create the kind of wonder that's revolutionized... ...working with large, complex datasets across multiple formats (CSV, Excel, databases, etc.) ~ Prior work experience at the company...Work experience placementImmediate start
Artech
Cupertino, CA6 days ago - ...Job Summary: The Senior Data Integration Analyst is responsible for analyzing, designing, and supporting the exchange of data between... ...Strong understanding of data formats such as JSON, XML, CSV, and relational data Knowledge of REST/SOAP APIs and integration...Work at officeFlexible hours
Ardan
Maitland, FL3 days ago - ...Title: Senior Data Analyst - Staff Engineer I Location: Phoenix, AZ Duration :: 12... ...experience with data analysis specifically as it relates to enterprise data management... ...experience using common file formats such as CSV, TEXT, JSON, XML, XSD, etc. ~...
Georgia IT Inc
Phoenix, AZ10 hours ago - ...accounts receivable management company seeking a part-time Data Analyst to manage the transfer of client data files into our enterprise... ...work with and convert various file types including txt, xml, xlsx, csv, etc. Typing speed at least 60 WPM Excellent written and...Part timeWork at office
Remex Inc
Skillman, NJ2 days ago - ...As an Electronic Data Interchange (EDI) Analyst Level 1, you will play a key role in designing, implementing, and maintaining data interchange... ...programming and coding languages, including C++, Java, XML, CSV, and SQL. ~ Strong understanding of software design principles...16 hoursTemporary workRemote workWork from homeWorldwideMonday to ThursdayFlexible hours
Jazwares
Plantation, FL10 hours ago $100k - $110k
...Ocean Advisor Data Analyst Description: Data Technologist Company: Ocean Advisor Target Start Date: June 1, 2026 Location... ...Coordinator). Technical Literacy: Proficient in Excel and CSV manipulation. SQL Knowledge: Familiarity with SQL and basic...Remote workOpenReq
Newport Beach, CA10 hours ago- ...Sr. Data Analyst DemandMatrix is a team of smart data scientists, data analysts and technologists who have the domain expertise of tech... ...a data solution. Working with varied data formats like JSON, CSV, XML, HTML, etc to extract information for the business case....Work from homeFlexible hours
DemandMatrix by DemandBase
United States1 day ago - ...We are seeking a Data Analyst with hands‑on experience using Large Language Models (LLMs) such as ChatGPT, Claude, or similar AI tools... .... Familiarity with structured and unstructured data formats (CSV, JSON, text, etc.). Strong analytical mindset, attention to detail...Remote work
Simera
San Francisco, CA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to IT CSV Analyst. Be the first to apply!
Related searches
- document review analyst United States
- facility analyst United States
- senior strategy analyst United States
- disaster recovery analyst United States
- consulting analyst United States
- contracts analyst United States
- compensation analyst United States
- due diligence analyst United States
- invoice analyst United States
- import analyst United States