Information Technology Usa Usa Lead

Posted on: Jul 21, 2026

Sysmind LLC
Raritan, New Jersey
Salary: $176,800 per year
Onsite
CTC

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Job Title :

Information Technology Usa Usa Lead

Job Type :

CTC

Job Location :

Raritan New Jersey United States

Remote :

Job Description :

**Please strictly adhere to the following resume naming convention:
ALL CAPS, NO SPACES B/T UNDERSCORES

Bill Rate $80 - $85

PTN_US_GBAMSREQID_CANDIDATEBEELINEID
i.e. PTN_US_9999999_SKIPJOHNSON0413

MSP Owner: Zach Provence
Location: Raritan, NJ
Duration: 6 months
GBaMS ReqID: 10859513

Role Descriptions: Demonstratable Experience in Computer System Validation (CSV)
Experience in software development processes (SDLC) and software testing life cycle (STLC)
Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation.
Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI
Strong knowledge of JIRA, HP-ALM, qTest tools
Knowledge of validation & testing in projects implemented using agile methodology
Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc.
Ability to take and understand the commitment to deliver the product on time.
GxP experience is required
Experience of validation support for 21 CFR Part 11 implementation in Pharma industries.
Leading the Tech Writer team for preparing the test cases.
Co-ordinating the testing with the business and automation test teams.
Experience working within a FDA/Other regulated pharma industry.

Roles & Responsibilities
Meeting with system users to understand the scope of projects
Participating in business requirement discussions to draft SDLC /CSV /Qualification documents.
Developing validation/qualification/migration/verification strategies for software
Executing validation/qualification/verification/migration strategies per quality assurance SOPs..
Providing validation/verification/qualification recommendations to stake holders as necessary.
Managing relationships with customers, technical team, quality assurance team, testing team and other stake holders to ensure the validation/ verification/qualification solution delivered to the customer meets expectations.
Ensuring SDLC/CSV/Qualification activities are conducted as planned
Generate, review, and Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports etc.
Working towards project deadlines
Communicating findings to technical and non-technical colleagues.
Liaising with project teams in other parts of the world
Leading the validation effort.
Generic Managerial Skills, If any
Strong verbal and written communication skills with the ability to liaise with a variety of stakeholders
Must be self-motivated and pro-active
Need to show constant dynamism and able to manage pressure.
Attention to detail
Competent CSV skills
The ability to work in a team and individually
Organizational skills with the capability of working towards tight deadlines
Able to work with demanding customer

Essential Skills: Life Sciences : Computer System Validation
Desirable Skills:
Keyword:
Skills: Life Sciences : Computer System Validation~Project Management
Experience Required: 6-8

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