CSV Analyst
Katalyst HealthCares & Life Sciences
Job-ID32471339Reference26-01027 Job Summary: We are seeking a CSV Analyst with Instrument Integration & Validation expertise to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments. The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows. This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements. Roles & Responsibilities: Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines. Develop and execute validation protocols including IQ, OQ, and PQ. Ensure systems remain in a validated state throughout their lifecycle. Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices. Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards. Gather and document system requirements. Develop software specifications, validation test cases, and supporting documentation. Create infrastructure diagrams, data flow diagrams, and document current system configurations. Perform functional, integration, regression, and data integrity testing. Identify, document, and troubleshoot validation deviations. Conduct root cause analysis and collaborate with cross-functional teams for issue resolution. Conduct risk assessments (FMEA) to identify and mitigate system risks. Support change control processes for software updates and enhancements. Assist in transitioning legacy SOPs to updated IT/software management SOPs. Perform regulated laboratory validation activities. Support requirements gathering and documentation. Author and execute validation test cases. Perform IQ/OQ/PQ, UAT, and end-to-end testing. Conduct risk assessments and support change control activities. Perform technical writing and objective evidence collection. Verify data integrity across systems. Support instrument integration workflows. Work with Instrument Manager or similar middleware. Validate instrument-to-middleware-to-LIS data flow. Support LIS, downstream reporting, and QC-related workflows. Ensure alignment with CAP, CLIA, 21 CFR Part 11, and GAMP risk-based validation expectations. Education & Experience: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field. 2–5+ years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical device industries. Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5. Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower). Experience with validation lifecycle processes, documentation standards, and data integrity principles. Strong regulated laboratory validation experience in Instrument Integration & Validation.
- ...lab validation experience in Instrument integration & Validation Analyst to support validation and compliance of laboratory,... ...field. 2 5+ years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical...SuggestedRemote work
- Taxpayer Advocate Service A description of the business units can be found at: Position(s) are to be filled in following area(s): TAS - Deputy National Taxpayer Advocate - Taxpayer Advocate ServicesSuggested
- Job Title The following is the job description for the position: Duties The following are the duties of this position at the full working level. If this vacancy includes more than one grade and you are selected at a lower grade level, you will have the opportunity...Suggested
- ...Quality Assurance Analyst SeniorWe are seeking a highly skilled and detail-oriented Data Quality Engineer to join our dynamic team.The ideal candidate will have a strong background in SQL, data warehousing, ETL processes, and test automation.This role requires a proactive...Suggested
- ...needs. We provide excellent benefits such as medical, dental, vision ++ a fun company to work!!!We are looking for a Business Systems Analyst with at least 6+ years of experience and strong data related project experience. Previous Banking/Finance domain is required.Top...Suggested
- ...employees globally and products sold in 130 countries, we specialize in security around the doorway and beyond.The Business Applications Analyst will serve as a key techno-functional lead for the Hollow Metal Door Strategic Business Unit (SBU) at Allegion. This role is...Temporary workRemote work
- ...Business Systems Analyst Sr, ERP (Financial Aid), Digital Technology SolutionsServe as systems liaison between the education, research, and administrative functions of the university and Digital Technology Solutions to help business units achieve their desired business...Work experience placementWork at officeFlexible hours
- ...a liaison between business and technology partners to drive solution delivery. Supports development of less experienced business analysts and team members. Responsibilities include, but are not limited to, communicating delivery status, estimating effort associated with...Work at officeShift work
- ...Sr. Business Systems Analyst IIIRequired Skills & Experience• 10+ years of PeopleSoft experience, troubleshooting production issues • 5+ years of PeopleSoft Campus Solutions Financial Aid experience o Deep functional and technical understanding of Financial Aid processing...Work at office
- ...Business Analyst Provide support and be involved in development of various business initiatives with limited supervision. Role will require custom reporting for operational business analytics utilizing Power BI, Excel, and Tableau. Must develop a strong comprehension...Work at officeLocal area
- Data AnalystLocation: Cincinnati, OH Duration: 6 MonthsEssential Duties And Responsibilities1. Institutional Brokerage Analysis Conduct in-depth analysis of securities trade processing including data mapping and ETL development.2. Reporting And Visualization Develop and...
- To Apply for this Job Click HereOpen to Raleigh or Cincinnati candidatesAssociate Data Analyst (Data Analyst 1 Transmission) Is the entry level position of Data Intelligence & Solutions Group. As such provides a support role in data processes (data analysis, maintenance...Work at office
- Data And Analytics SupportSupport 1-2 product areas’ data and analytics needs from new tagging to reports to insights. This role will enable product teams to make data driven decisions to inform the roadmap of their product. They will assist in discoveries and understand...
- ...Job-ID Reference Remote50% Remote Job Description: The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene...Remote work
- ...Great American Insurance Group is seeking a strategic, data-focused analyst to join its Crop Insurance team in a hybrid role. You will detect processing errors, analyze data with SQL, and coordinate cross-functional fixes while ensuring compliance with insurance requirements...
- ...Lead Data AnalystLocation: Cincinnati, OH (Onsite)Duration: Long TermWe’re seeking a Lead Data Analyst with strong experience in P&C Insurance to drive end-to-end analytics initiatives. You’ll lead a team, define KPIs, and deliver actionable insights to senior leadership...
- Great American Insurance Group, Crop Division, seeks a data-and-analytics focused professional for a hybrid role combining in-office collaboration with remote work. You will analyze data, write SQL to support crop insurance operations, and deliver insights to stakeholders...Work at officeRemote work
- Job SummaryOur corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Standard Analyst to join our Biostatistics team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’...Full timeContract workWork at officeWork from home
- ...Lead Data AnalystThe LEAD DATA ANALYST will dive in deep to swim with our data and technology to solve real customer problems in ways that meet the needs of the business. You will work with your key stakeholders and partners to understand, map and solve problems with our...
- Overview This position leads enhancements to data quality management platform and analyzes data for accuracy. Responsible for implementing business solutions that use data to streamline processes. Uses data profiling of additional data sources in determining accuracy...Casual workWork at office
- ...one of the leading Clinical Research Organizations companies in Healthcare. We are hiring a full-time talented Information Security Analyst who is technical, dedicated to learning new things, security-minded, strong initiative, and able to manage projects autonomously....Full timeContract workInternshipWork from home
- ...Job Title: Sr. Business Analyst (SAP Finance & Accounting) Job Type: Contract-to-Hire (Hybrid, Cincinnati OH area) Must be authorized to work in the United States (no sponsorship) Overview We’re looking for a Senior Business Analyst with strong SAP S/4HANA Finance (FI/...Contract work
- - The Business Analyst is a critical member of the Program Data Analytics team, responsible for partnering with Program Directors and stakeholders to ensure effective Program management and continuity. This role is central to translating business requirements into actionable...Temporary workLocal areaFlexible hours
- ...Senior Business AnalystRequired Skills & Experience:Business Analyst experience with strong requirements elicitation and documentation skillsExperience with data mapping, data analysis, and documenting back-end system requirementsStrong communication skills with the ability...
$49 - $59 per hour
...Business Analyst - Cincinnati, OH - Contract - $49-59 per HRThis position is for a Business Analyst with a focus on the life insurance domain, located in Cincinnati, OH. The role is a contract position requiring onsite presence and involves working with various business...Contract work- ...Business Analyst VLocation: Cincinnati, Ohio 45227Contract: 6-12+ MonthsJob DescriptionMust Have:1+ year(s) of Gen AI related development7+ years of experience in software quality engineering, test automation, software testing, or closely related technology roles, with...
- ...Business AnalystOn-site in Cincinnati, OHOur client seeks a Business Analyst to lead a Vulnerability and Patch Automation Initiative. The role drives the vision, roadmap, and execution of enterprise efforts to accelerate vulnerability remediation, automate patch management...
- ...Core Specialty is seeking a Business Analyst to join the Program Data Analytics team. You will partner with Program Directors to translate business requirements into actionable insights and ensure data accuracy across delegated authority and underwriting controls. You...
- ...senior management;QualificationsBachelor's Degree in Business, Computer Science, or Related Degree1+ years of experience as an HRIS Analyst, HR Systems Analyst, Business Analyst, Business Systems Analyst, or related.Medpace OverviewMedpace is a full-service clinical...Contract workWork at officeWork from home1 day per week
- ...and identify talent - often in combination - to an endless array of real-world customer needsJob DescriptionTitle: Business System Analyst Location: Cincinnati, OH Type: Fulltime // PermanentInterview Process: Phone and Skype HireEnd Customer: Banking domainJob Description...Full time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CSV Analyst. Be the first to apply!
- recruiting analyst Cincinnati, OH
- power bi analyst Cincinnati, OH
- facility analyst Cincinnati, OH
- strategic sourcing analyst Cincinnati, OH
- integration analyst Cincinnati, OH
- database analyst Cincinnati, OH
- call center workforce analyst Cincinnati, OH
- ecommerce analyst Cincinnati, OH
- health program analyst Cincinnati, OH
- data loss prevention analyst Cincinnati, OH


