Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, Pharmaceutical Sciences, or a related field.
1-2 years of experience in Computer System Validation (CSV), Quality Assurance, or Compliance in regulated environments.
Strong understanding of validation principles and data integrity.
Familiarity with GxP regulations and FDA compliance requirements.
Relevant coursework in Computer System Validation or Regulatory Compliance is a plus.
Responsibilities
Support planning, execution, and documentation of CSV activities for GxP systems.
Perform system impact and risk assessments, and contribute to validation strategies.
Execute validation tests and document results, including any deviations.
Ensure compliance of validation deliverables with FDA regulations and GxP standards.
Assist in reviewing systems for electronic records compliance.
Support CAPA, change control, and validation lifecycle activities as needed.
Collaborate with cross-functional teams across Quality Assurance, IT, and Engineering.
Benefits
Participate in internal and external audits, providing necessary documentation.
Maintain accurate validation records according to regulatory requirements.
Stay updated with regulatory requirements, industry standards, and best practices in CSV.
Full Job Description
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.
