Validation Analyst: CSV, GxP & Compliance Expert

TechDigital Group; Secaucus (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A regulatory compliance firm in New Jersey is seeking a Validation Analyst responsible for planning and executing validation activities to ensure compliance with regulatory standards like FDA and GxP. Key responsibilities include developing validation documentation, performing validation testing, and collaborating with teams across IT, QA, and Manufacturing. Candidates should have a Bachelor's degree and 2-5 years of industry experience. This role provides an opportunity to support compliance in a dynamic work environment.

Qualifications

• 2–5 years of experience in Validation, Quality Assurance, or Compliance within regulated industries.
• Strong knowledge of GAMP 5 and FDA 21 CFR Part 11.
• Familiarity with data integrity principles.

Responsibilities

• Develop and maintain validation documentation.
• Perform Computer System Validation activities.
• Collaborate with cross-functional teams for validation deliverables.

Skills

Computer System Validation principles

Risk-based validation

Documentation tools proficiency

Analytical skills

Communication skills

Education

Bachelor's degree in Life Sciences, Engineering, Computer Science

Tools

MS Office Suite

Job description

A regulatory compliance firm in New Jersey is seeking a Validation Analyst responsible for planning and executing validation activities to ensure compliance with regulatory standards like FDA and GxP. Key responsibilities include developing validation documentation, performing validation testing, and collaborating with teams across IT, QA, and Manufacturing. Candidates should have a Bachelor's degree and 2-5 years of industry experience. This role provides an opportunity to support compliance in a dynamic work environment.