Lead CSV Validation Engineer - MES/GxP Systems

Raas Infotek; Raritan (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Raas Infotek is looking for a qualified candidate for a role focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant experience.

Key responsibilities include project coordination, managing stakeholder communication, and expertise in GxP compliance documentation. The role also requires effective leadership skills and the ability to collaborate with remote teams.

Qualifications

• 7-10 years of experience in Technology Quality Manufacturing, particularly with GxP systems.
• Independent leadership in validation activities across the SDLC.
• Expertise in validation documentation including compliance plans and test reports.

Responsibilities

• Lead validation activities across the SDLC for GxP systems.
• Manage project coordination and stakeholder communication.
• Write and review documentation such as Compliance Plans and Test Reports.

Skills

CSV expertise

Quality expertise

GxP compliance

Leadership skills

Project coordination

Stakeholder communication

Agile Tools

Tools

Jira

Xray

qTest

Job description

Raas Infotek is looking for a qualified candidate for a role focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant experience.

Key responsibilities include project coordination, managing stakeholder communication, and expertise in GxP compliance documentation. The role also requires effective leadership skills and the ability to collaborate with remote teams.