Validation Analyst

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

Role Overview: The Validation Analyst is responsible for planning, executing, and documenting validation activities to ensure compliance with regulatory requirements (FDA, EMA, GxP, HIPAA, SOX) and internal quality standards. This role supports Computer System Validation (CSV), equipment qualification, and process validation across the organization.

Key Responsibilities

• Develop and maintain validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
• Perform Computer System Validation (CSV) activities in alignment with GAMP 5 and 21 CFR Part 11 guidelines.
• Ensure compliance with GxP, ICH Q9/Q10, and other applicable regulatory standards.
• Execute validation testing, record results, and manage deviations/CAPA as required.
• Collaborate with cross-functional teams (IT, QA, Manufacturing, R&D) for validation deliverables.
• Support audit readiness and respond to regulatory inspections.
• Maintain validation traceability matrices and ensure proper documentation control.
• Participate in periodic reviews and re-validation activities for systems and equipment.

Required Skills & Qualifications

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
• 2–5 years of experience in Validation, Quality Assurance, or Compliance within regulated industries.
• Strong knowledge of CSV principles, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and HIPAA.
• Familiarity with risk-based validation approaches and data integrity principles.
• Proficiency in documentation tools and MS Office Suite.
• Excellent analytical, problem-solving, and communication skills.

Preferred Qualifications

• Experience with ERP/LIMS/Clinical Systems validation.
• Knowledge of automation tools and AI-enabled compliance workflows.
• Certifications such as ISPE GAMP, ASQ CQE, or CSV Specialist are a plus.