What are the responsibilities and job description for the CSV Engineer - Raritan, NJ position at Silverlink Technologies LLC?
Job Details
We are looking for a CSV Engineer to join our team. Please review the job description below, and let us know if you are interested and available.
If this opportunity matches your experience and career goals, we would love to discuss it more. Additionally, feel free to share your updated resume for consideration.
Role - CSV Engineer
Location - Raritan, NJ (Hybrid 3 days a week)
Job Details:
Skills- Computer System Validation, GxP Regulations
SS- Validating Lab Information Management System - LIMS, LIMS Rollover
JD-7-10years experience in Computer System Validation of Lab Information Management System - LIMS
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 StrategyTest Planning, ValidationTest 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.
Best Regards,
Sumit Talekar
Associate Manager Talent Acquisition
Silverlink Technologies Inc.
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