Net2Source (N2S) logo

Validation Specialist

Net2Source (N2S) New Brunswick, New Jersey, United States

onsitefull-time

Salary: 21 CFR Pa

Posted Jan 7, 2026Apply by Jul 31, 2026

Role & seniority: Validation Specialist (contract, likely mid-senior, 6+ months)

Stack/tools: FDA/MHRA and global health regulations; CSV deliverables; 21 CFR Part 11; MS Office (Advanced), Visio; EDM systems (Documentum, Qumas, SharePoint); application lifecycle tools (Client ALM, JIRA); ITSM (ServiceNow, SAP Solution Manager)

Top 3 responsibilities

  • Apply regulatory requirements to development of computer systems and facilitate Computer System Validation (CSV) risk assessment

  • Review validation deliverables (Requirements/Design specs, CSV Risk Assessment, Test Plans/Summaries, Data Migration, Traceability Matrix, Release to Production)

  • Plan/execute user acceptance testing, oversee testing activities, advise on quality issues, and approve validated system change requests; maintain stakeholder communication

Must-have skills

  • Deep knowledge of CSV processes and regulatory compliance (FDA, MHRA, 21 CFR Part 11)

  • Strong documentation skills and ability to create/maintain standard documents

  • Excellent written/verbal English communication; ability to work independently in a matrixed organization

  • Experience reviewing/producing validation documents and risk assessments; ability to train others

Nice-to-haves

  • Experience with documents/EDM tools (Documentum, Qumas, SharePoint); ALM/JIRA; ITSM tools (ServiceNow, SAP Solution Manager)

  • Prior experience in validated computer systems projects and UAT planning

  • Location & work type: New Brunswick,

Full Description

Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring "Validation Specialist" for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering.

Position: Validation Specialist

Location: New Brunswick, NJ

Duration: 6+ months on W2

Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues Assist in planning, implementing, and documenting user acceptance testing

Review computerized systems validation documents such as

  • Requirements Specification

  • Design Specification

  • CSV Risk Assessment

  • Test Plans

  • Test Summary Reports

  • Data Migration Plan

  • Pre/Post Executed Test Scripts

  • Traceability Matrix

  • Release to Production Statements

Direct and review testing Provide guidance on quality issues that affect the integrity of the data or the system Obtain and respond to QA review Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions Approve validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action Ability to create documents to an existing document standard. Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc) Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Once trained, have the ability to work independently on CSV projects with minimal oversight. Ability to perform in a highly matrixed organization structure.

About Net2Source, Inc. Net2Source is an employer-of-choice for over 2200+ consultants across the globe. We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us! Want to read more about Net2Source? Visit us at www.net2source.com

Equal Employment Opportunity Commission

  • The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
  • Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 2200+ employees globally and 30 locations in US and operations in 20 countries. With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs. We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services.

Fast Facts about Net2Source

  • Inception in 2007, privately held, Debt free

  • 2200+ employees globally

  • 375+ In- house Team of Sales, Account Management and Recruitment with coast to coast COE.

  • 30 offices in US and 50+ Offices globally

  • Operations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)

Awards and Accolades

  • 2018 - Fastest Growing IT Staffing Firm in North America by Staffing Industry Analysts

  • 2018 - Fastest-Growing Private Companies in America as a 5 times consecutive honoree - Inc. 5000

  • 2018 - Fastest 50 by NJBiz

  • 2018 - Techserve Excellence Award (IT and Engineering Staffing)

  • 2018 - Best of the Best Platinum Award by Agile1

  • 2018 - 40 Under 40 Award Winner by Staffing Industry Analysts

  • 2018 - CEO World Gold Award by SVUS

  • 2017 - Best of the Best Gold Award by Agile1

Thanks & Regards Neel Bhavsar Technical Recruiter

Desk: (201) 479-1167| Email: neelb@net2source.com

multi-location

Cookies & analytics consent

We serve candidates globally, so we only activate Google Tag Manager and other analytics after you opt in. This keeps us aligned with GDPR/UK DPA, ePrivacy, LGPD, and similar rules. Essential features still run without analytics cookies.

Read how we use data in our Privacy Policy and Terms of Service.