CSV Engineer: GxP Validation & Compliance

Katalyst-Healthcares-; San Diego (CA); Vor Ort; USD 70.000 - 95.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CSV validation

Regulatory compliance

Data integrity

Documentation

FDA regulations

GxP

Quality Assurance

Ausbildung

Bachelor's degree in engineering / related field

Jobbeschreibung

Job Summary:
We are seeking a motivated and detail-oriented Computer System Validation (CSV) Engineer with 1–2 years of experience to support validation and compliance activities within the Pharmaceutical and Medical Devic e industries. The ideal candidate will assist with the validation of computerized systems in regulated GxP environments and ensure systems comply with applicable regulatory and quality requirements. The candidate should have a strong understanding of validation principles, documentation practices, data integrity, and regulatory expectations.
Roles and Responsibilities:

• Support the planning, execution, and documentation of Computer System Validation (CSV) activities for GxP-regulated computerized systems.
• Support system impact assessments, risk assessments, and validation strategy development.
• Execute or assist with validation test scripts and document test results, deviations, and observations.
• Ensure validation deliverables comply with applicable FDA regulations, GxP requirements, 21 CFR Part 11, and Data Integrity principles.
• Assist with reviewing computerized systems for compliance with electronic records and electronic signatures requirements.
• Support deviation, change control, CAPA, and validation lifecycle activities as required.
• Collaborate with Quality Assurance, IT, Engineering, Manufacturing, and other cross-functional teams.
• Maintain accurate and complete validation records in accordance with company procedures and regulatory requirements.
• Participate in internal and external audits by providing appropriate validation documentation and support.
• Identify potential compliance gaps and assist in developing appropriate remediation activities.
• Stay current with relevant regulatory requirements, industry standards, and CSV best practices.

Education & Experience:

• Bachelor's degree in engineering, Computer Science, Information Systems, Life Sciences, Pharmaceutical Sciences, or a related technical field.
• Relevant coursework or training in Computer System Validation, GxP, Quality Assurance, Regulatory Compliance, or Software Quality is a plus.
• 1–2 years of professional experience in Computer System Validation (CSV), Validation, Quality Assurance, Compliance, or a related regulated industry.
• Experience supporting validation activities within the Pharmaceutical, Biotechnology, Medical Device, or other FDA-regulated industries is preferred.