🤖 15+ AI Agents working for you. Find jobs, score and update resumes, cover letter, interview questions, missing keywords, and lots more.
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.
🤖 15+ AI Agents working for you. Find jobs, score and update resumes, cover letter, interview questions, missing keywords, and lots more.
Net2Source (N2S) • Tampa, Florida, United States
Salary: 21 CFR Pa
Role & seniority: Validation Specialist, mid-to-senior (6+ years experience)
Stack/tools: Regulatory frameworks (FDA, MHRA, global health authorities); Computer System Validation (CSV); 21 CFR Part 11; MS Office (Advanced); Visio; electronic document management systems (Documentum, Qumas, SharePoint); application lifecycle tools (Client ALM, JIRA); ITSM systems (ServiceNow, SAP Solution Manager)
Apply regulatory requirements to computer systems supporting regulated processes; conduct CSV risk assessments; develop and review validation deliverables (e.g., Requirements/Design Spec, CSV Risk Assessment, Test Plans, Test Reports, Data Migration Plan, Traceability Matrix, Release to Production)
Plan, implement, document user acceptance testing; direct and review testing; provide guidance on quality issues and ensure data/system integrity
Maintain stakeholder communications; obtain/respond to QA reviews; participate in standardization of quality/validation practices; approve validated change requests; monitor regulatory trends
6+ years in CSV/regulatory validation for computer systems; strong knowledge of FDA, MHRA, and global health authority regulations; Good Documentation Practices and Good Testing Practices
Ability to create/align documentation to 21 CFR Part 11; independent work on CSV projects; excellent written/spoken English; effective interviewing/requirements interpretation
Experience with EDC/EDMS
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.
Please find below the job description.
Company: One of Our Clients
Position: Validation Specialist
Location: Tampa, FL 33634
Duration: 6 months contract on W2
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
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.
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)
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, Rushi Adhyaru Sr. Technical Recruiter
Phone: 201-479-3705 (ext.: 806)| Email: rushia@net2source.com