Talent.com
Katalyst HealthCares & Life Sciences
IT CSV AnalystKatalyst HealthCares & Life Sciences • Remote, NJ
IT CSV Analyst

IT CSV Analyst

Katalyst HealthCares & Life Sciences • Remote, NJ
30+ days ago
Job type
  • Full-time
  • Remote
Job description

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 CFR Part , EU Annex , GAMP , 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 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.
Requirements:
  • Bachelor's degree in computer science, Information Technology, Life Sciences, or related field.
  • Minimum – 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 CFR Part , EU Annex , and GAMP .
  • 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 (, Veeva, Master Control, Kneat).
  • Knowledge of cloud-based validation and SaaS compliance.
  • Understanding data integrity and cybersecurity principles in a regulated environment.

Create a job alert for this search

IT CSV Analyst • Remote, NJ

Similar jobs

Remote Senior Financial Analyst - AI Trainer ($50-$60 per hour)

Data AnnotationHighland Park, New Jersey
$50.00 hourly
Remote
Full-time +1

DataAnnotation is committed to creating high-quality AI.Join our team to help train the next generation of AI while enjoying the flexibility of remote work and the freedom to set your own&nbsp... Show more

 • Promoted

IT Vendor Management Analyst

Hackensack Meridian HealthEdison, NJ, United States
Full-time +1

Information Technology (It) Vendor Management Analyst.Our team members are the heart of what makes us better.At Hackensack Meridian Health we help our patients live better, healthier lives and we ... Show more

 • Promoted

Sr Analyst, IT QA # 26-12270

US Tech SolutionsWhippany, New Jersey, US
Full-time +1

Duration: 6 months contract, Full-Time.Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.The Senior Analyst, IT QA is accountable t... Show more

 • Promoted

COO / IT Director (MSP)

Bowman WilliamsVillage of Farmingdale, NY, United States
Full-time

A fast-growing Managed Service Provider is seeking a.This is a critical second-in-command role, ideal for a high-performing operations leader with a strong background in IT services, MSPs, or techn... Show more

 • Promoted

SAP Analyst

BCforwardNew Brunswick, NJ, United States
Full-time

One Squibb Drive, New Brunswick, NJ 08903.Troubleshoot SAP issues and provide technical support for MFG sites and External Manufacturing (ExM).Collaborate with IT on help desk tickets and provide s... Show more

 • Promoted

Director, RWE Analysis Oversight – Inflammation

Scorpion TherapeuticsParsippany-Troy Hills, NJ, United States
Full-time

Scorpion Therapeutics in Parsippany-Troy Hills, NJ is looking for a Data Scientist/Analyst to oversee timely and quality analysis results.The role involves managing vendor performance and data stra... Show more

 • Promoted

Data Integrator

TechDigital GroupNew Brunswick, NJ, United States
Full-time

Product Development (PD) at Client is committed to accelerating CMC development to launch through strategic investments in Client development and manufacturing platforms, new development playbooks,... Show more

 • Promoted

Sales Executive (IT Staffing and Solutions)

PierceHolmdel, NJ, United States
Full-time

We are an IT staffing and solutions company based in Holmdel, NJ that has been delivering IT projects and resources to our clients for over 20 years.When you work for Pierce, we keep an open ear to... Show more

 • Promoted

Senior ServiceNow ITSM Consultant — IT Transformation Leader

EYWoodbridge Township, NJ, United States
Full-time

EY is seeking a ServiceNow Senior Consultant in Woodbridge Township, NJ, to lead transformation teams for IT Service Management (ITSM).This role involves engaging with clients, managing a multi-dis... Show more

 • Promoted

Senior ServiceNow Architect: Enterprise IT & Cloud

AccentureMorristown, NJ, United States
Full-time

Accenture is seeking a Technical Architect for its ServiceNow Business Group in Morristown, New Jersey.This role involves crafting solutions in ServiceNow, leading development teams, and advising C... Show more

 • Promoted

Sr. Solutions Architect, Data Center & Cloud (NYC/NJ)

Presidio Networked Solutions, LLCMorristown, NJ, US
Full-time

Presidio, Where Teamwork and Innovation Shape the Future.AtPresidio, we're at the forefront of a global technology revolution, transforming industries throughcutting-edge digital solutions and next... Show more

 • Promoted

Sr. Financial Systems Analyst, Order to Cash (Zuora)

RelativityNewark, NJ, US
Full-time

The Senior Financial Systems Analyst serves as the end-to-end process subject matter expert for Zuora, owning platform administration and providing daily system support for Billing, Collections, an... Show more

 • Promoted

Senior Alliance Sales Exec – ServiceNow for FS

EYWoodbridge Township, NJ, United States
Full-time

EY is seeking an Alliance Sales Executive for the Financial Services sector.The successful candidate will originate new business, foster relationships with ServiceNow, and drive sales opportunities... Show more

 • Promoted

ServiceNow - IT Service Management (ITSM) - Senior - Tech Consulting - Open Location

EYWoodbridge Township, NJ, United States
Full-time

At EY, we’re all in to shape your future with confidence.We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.ServiceNow Senior... Show more

 • Promoted

Data Center Project Manager

TEKsystemsSomerset, NJ, US
Temporary

Data Center Project Manager (Contract) *Location:* On-site - Franklin Township, NJ 08873.About the Role TEKsystems is seeking an experienced *Data Center Project Manager* to lead planning and execu... Show more

 • Promoted

VP, IT Data & Analytics, Reporting and Analytics

Allied WorldWoodbridge Township, NJ, United States
Full-time

VP, IT Data & Analytics, Reporting and Analytics (2500002I).VP, Reporting & Analytics mission is to establish a Data-as-a-Product practice in Allied World, drive the design and delivery of data pro... Show more

 • Promoted

Senior Data Analyst - Call Center Operations (Remote)

Analytic Recruiting Inc.Berkeley Heights, NJ, United States
Remote
Full-time

Job Description :Our client, a fast-growing technology company (MarTech / InsurTech) specializing in customer acquisition and lead generation, is seeking a Senior Data Analyst to optimize Call Cent... Show more

 • Promoted

Hourly Data Analyst

New Jersey Institute of TechnologyNewark, NJ, US
Part-time

Electrical and Computer Engineering.Heat is an inherent part of gasoline-powered (e.Heat is also generated from wastelands and the project aims at using the, otherwise wasted thermal energy, as an ... Show more

 • Promoted

Clinical Informatics Manager - Health IT Leader

RWJBarnabas HealthNew Brunswick, NJ, United States
Full-time

RWJBarnabas Health is looking for a Manager of Clinical Informatics to integrate clinical science with information management.The role requires a graduate degree and clinical licensure in NJ.The ma... Show more

 • Promoted

Sr Director, IT - Global Commercial Digital Services

Teva PharmaceuticalsParsippany-Troy Hills, NJ, United States
Full-time

Teva is a leading biopharmaceutical company with a world‑class generics business, innovating in neuroscience and immunology and delivering high‑quality medicine worldwide.As part of a high‑performi... Show more