CSV Engineer: GxP Validation & Compliance

Creative Solutions Services, LLC; San Diego (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a motivated CSV Engineer with 1–2 years of experience to support validation and compliance activities in FDA‑regulated environments. You will help validate computerized systems, ensure data integrity, and maintain documentation in line with GxP requirements.

You will collaborate with QA, IT, engineering, and manufacturing to execute validation tests, assess risks, and support audits. A bachelor's degree in a technical field is required.

Qualifications

• Bachelor's degree in engineering, Computer Science, Information Systems, Life Sciences, Pharmaceutical Sciences, or related technical field.
• Coursework/training in Computer System Validation, GxP, QA, Regulatory Compliance, or Software Quality is a plus.
• 1–2 years of professional CSV/validation experience in regulated industries.
• Experience in Pharmaceutical, Biotechnology, Medical Device, or other FDA-regulated industries preferred.

Responsibilities

• Support planning, execution, and documentation of CSV activities for GxP-regulated systems.
• Assist with system impact assessments, risk assessments, and validation strategy development.
• Execute or assist with validation test scripts and document results, deviations, and observations.
• Ensure validation deliverables comply with FDA regulations, GxP, 21 CFR Part 11, and data integrity principles.
• Assist with reviewing systems for compliance with electronic records and signatures.
• Support deviation, change control, CAPA, and lifecycle validation activities.
• Collaborate with Quality Assurance, IT, Engineering, Manufacturing, and cross-functional teams.
• Maintain accurate validation records per procedures and regulations.
• Assist in audits by providing validation documentation and support.
• Identify compliance gaps and aid remediation activities.
• Stay current with regulatory requirements and CSV best practices.

Skills

CSV validation

Regulatory compliance

Data integrity

Documentation

FDA regulations

GxP

Quality Assurance

Education

Bachelor's degree in engineering / related field

Job description

Creative Solutions Services, LLC is seeking a motivated CSV Engineer with 1–2 years of experience to support validation and compliance activities in FDA‑regulated environments. You will help validate computerized systems, ensure data integrity, and maintain documentation in line with GxP requirements.

You will collaborate with QA, IT, engineering, and manufacturing to execute validation tests, assess risks, and support audits. A bachelor's degree in a technical field is required.