CSV Engineer

TechDigital Group; Raritan (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a seasoned professional with over 8 years of experience in Computer System Validation and Quality Management in GxP applications. This role involves guiding project teams through the SDLC, applying FDA guidance, and interacting with various stakeholders to interpret business requirements. You will support the Service Industrialization project by analyzing technologies, setting up mapping structures in SharePoint, and ensuring compliance with GxP classification. If you have strong communication skills and a passion for quality management, this is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

• 8+ years in Computer System Validation or Quality Management in GxP applications.
• Strong understanding of FDA guidance and 21 CFR Part 11.

Responsibilities

• Guide project teams with applicable deliverables based on project type.
• Analyze technologies for GxP classification and set up reporting.

Skills

Microsoft Sharepoint

Power Platform

Data Analytics

Dashboarding

Communication Skills

Job description

Note: The resource must have experience in Microsoft Sharepoint and Power Platform tools, data analytics and dashboarding.

Job Details:

1. 8+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
2. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.
3. Application of FDA guidance and industry standards (i.e., GAMP). Strong understanding of 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.
4. Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents.
5. This resource will support the following related to our Service Industrialization (SI) project:
1. Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets.
2. Design and set up Mapping Structure for TS Services in SharePoint List.
3. Record the technologies from the excel spreadsheets in the Mapping Structure for each Service.
4. Collect the CMDB information for each technology pulled from the spreadsheets.
5. Analyze technologies collected manually for GxP classification.
6. Analyze hierarchy and data attributes for Services.
7. Set up reporting to communicate status of progress Services supporting GxP use cases, Services' technologies identified, Services' technologies CMDB, GxP classification status.