Job Title: CSV Engineer

Location: Raritan, NJ - Onsite

Duration: 6+ months Contract

Job Description:

• 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
• Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
• Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner
• Ability to work with project team to facilitate interaction between Project team and Business Stake holders
• Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools
• Trains the project team on the relevant procedures associated with different SDLC processes and Tools
• Strong in Project Management tools like JIRA
• Manage Project priorities based upon identified risks.

Key Skills:

CSV, Servicenow, JIRA, 21 CFR Part11, GxP, FDA, Quality Management, GAMP, Validation.