Top 3 Csv analyst Jobs in Stony Brook, Ny

CSV Analyst
Katalyst Healthcares & Life Sciences —Bridgeport, CT
- Contract
- Computer Science
- 5 years
- Laboratory experience
Quick Apply
9d
Manager, Sage Implementation - Accounting Advisory/Private Accounting Solutions
Andersen —Melville, NY
- $112,000 - $180,000 a year
- CPA
- 3 years
- Finance
- Paid holidays
- Health insurance

More jobs to discover

Find similar jobs that you might be interested in.

Manager, Streaming Partnerships
Confidential —New York, NY
Partner with internal teams to develop promotional strategies for new channel launches, weekly and monthly programming, and editorial and seasonal events —…
$114,789.29 - $128,069.86 a year
Quick Apply
6d
Livestream E-commerce Account Manager - TikTok Shop
Sellery,Inc —New York, NY
1+ year of experience in account management, e-commerce, livestreaming, digital marketing, or a related field preferred. New York, NY 10018 (Required).
$4,000 - $5,000 a month
Quick Apply

Show more similar jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Business Systems Analyst II
American Regent, Inc. —New Albany, OH
Communicate effectively with both technical and non‑technical stakeholders using clear, structured communication and documentation.
Oracle Utilities Market Transaction Framework (MTF) Functional Lead
Accenture —Columbus, OH
We even built our own platform, myConcerto, that mixes the best parts of Accenture and Oracle to help companies come into their own as digital leaders.

I want to receive the latest job alert for csv analyst in stony brook, ny

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

csv analyst jobs near stony brook, ny

Accounting jobs in Wausau, WI

Accounting jobs in Durham, NC

Accounting Manager jobs in Long Island, NY

Accounting Manager jobs in Chattanooga, TN

Accounting Manager jobs in Neenah, WI

Accounting Manager jobs in Santa Barbara, CA

Hotel Manager jobs in Philadelphia, PA

CSV Analyst

Katalyst Healthcares & Life Sciences -
Bridgeport, CT

Quick Apply

Job Details

Contract
9 days ago

Qualifications

Data integrity assurance
Data validation techniques
Laboratory experience
Data integrity and documentation
Pharmaceutical company experience
CLIA regulations
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Laboratory information systems (LIS)

Full Job Description

Job Description:

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.

Requirements:

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.

Quick Apply

Refine Your Search

csv analyst jobs in stony brook, ny

CSV Analyst

Manager, Sage Implementation - Accounting Advisory/Private Accounting Solutions

More jobs to discover

Explore jobs in cities nearby

I want to receive the latest job alert for csv analyst in stony brook, ny

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected