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.

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