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Net2Source (N2S) • Princeton, New Jersey, United States
Salary: 21 CFR Pa
Role & seniority: Validation Specialist (mid-level to senior individual contributor)
Location & work type: Princeton, NJ 08543; 6-month contract / on-site with potential remote elements per client policy
Stack / tools: HP ALM; CSV/Database & Data Migration; 21 CFR Part 11 validation; MS Office (Excel, Word, PowerPoint); Visio; electronic document management (Documentum, Qumas, SharePoint); ALM/JIRA; ITSM (ServiceNow, SAP Solution Manager)
Review and approve validation documentation, change requests, and testing deliverables; ensure adherence to SOPs and regulatory standards (FDA, MHRA, 21 CFR Part 11)
Plan, execute, and document user acceptance testing; monitor validation status and communicate with stakeholders
Direct and review testing; approve validated computer system changes; identify gaps and recommend corrective actions; assess compliance practices
3–5 years HP ALM experience
3–5 years CSV experience covering Database/SQL and Data Migration
3–5 years CSV documentation experience
1–2 years Change Control experience
Strong written/spoken English; ability to work independently in a matrixed organization
Experience in data warehousing
Knowledge of GAMP categories/validation approaches
Strong communication skills
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.
Company: One of Our Clients
Position: Validation Specialist
Location: Princeton, NJ, 08543
Duration: 6 Months
This role will be responsible for reviewing and approving validation documentation, change requests and testing. He/She will work closely with the application test teams to ensure quality of validation deliverables and testing.
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
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. HP 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
Nice to have Experience in data warehousing Understanding of GAMP categories and validation approaches Good communication skills
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
Regards, Rahul Shribas Account & Delivery Manager | Net2Source
Office: (201) 299-3915 x Ext: 908 | Fax: (201) 221-8131| Email: rahuls@net2source.com