Computer System Validation Engineer

Role: Life Sciences : Computer System Validation Engineer
Location: Raritan, NJ- Onsite
Experience: 8 & Above
Duration: 12+ Months


Rate $50 - $55/hr(c2C)



Must Have:

• Life Sciences : Computer System Validation
• Software Product Development
• GxP experience is required

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 (STUATRegression) 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| Client-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.
• Experience working within a FDA
• Other regulated pharma industry.
• 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 SDLCCSV
• 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.
• 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: Validation Lead with AI knowledge

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.