NEWPosted 2 hours ago
Job ID: JOB_ID_7754
Job Summary:
Siri Info Solutions is seeking a skilled Computer System Validation (CSV) Engineer for a 6-month contract position located in Raritan, NJ. This role requires extensive experience in validation processes within regulated pharmaceutical industries, including GxP and 21 CFR Part 11 compliance.
Key Responsibilities:
- Demonstrate experience in Computer System Validation (CSV) and Software Development Life Cycle (SDLC) / Software Testing Life Cycle (STLC).
- Draft, review, revise, and maintain validation documents, including Compliance Analysis, Compliance Plan, Change Control Document, User Functional Requirement documents, Risk Assessments (Risk Register), Test (STUAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, and Operation Run Book.
- Draft Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Utilize tools such as JIRA, HP-ALM, and qTest.
- Apply knowledge of validation testing in projects using agile methodology and Agile techniques (User Stories, Continuous Testing, tasks).
- Understand and commit to delivering the product on time.
- Possess GxP experience and experience with 21 CFR Part 11 implementation in Pharma industries.
- Experience working within FDA and other regulated pharma industry environments.
- Meet with system users to understand project scope.
- Participate in business requirement discussions to draft SDLC CSV Qualification documents.
- Develop validation/qualification/migration/verification strategies for software.
- Execute validation/qualification/verification/migration strategies per quality assurance SOPs.
- Provide validation/verification/qualification recommendations to stakeholders.
- Manage relationships with customers, technical teams, quality assurance teams, and testing teams to ensure delivered solutions meet expectations.
- Ensure SDLC/CSV Qualification activities are conducted as planned.
- Generate, review, and manage Computerized Systems lifecycle documentation, including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Work towards project deadlines.
- Communicate findings to technical and non-technical colleagues.
- Liaise with project teams globally.
- Lead validation efforts.
Required Skills and Experience:
- Competent CSV skills.
- Validation Lead experience with AI knowledge is essential.
- Strong verbal and written communication skills.
- Ability to liaise with a variety of stakeholders.
- Self-motivated and proactive.
- Ability to manage pressure and show dynamism.
- Attention to detail.
- Ability to work both independently and in a team.
- Organizational skills with the capability of working towards tight deadlines.
- Able to work with demanding customers.
- Keywords: artificial intelligence, rlang, information technology, hewlett packard, New Jersey, Wisconsin.
Contract Details:
- Duration: 6 months – Contract
- Location: Raritan, NJ
Special Requirements
GxP experience is required. Experience of validation support for 21 CFR Part 11 implementation in Pharma industries. Experience working within a FDA. Other regulated pharma industry.
Compensation & Location
Salary: $60 – $80 per year (Estimated)
Location: Raritan, NJ
Recruiter / Company – Contact Information
Email: nash.r@siriinfoinc.com
Recruiter Notice:
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