Computer System Validation Engineer

San Diego, CA, US • Posted 23 hours ago • Updated 12 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Attention To Detail
  • Functional Requirements
  • Risk Assessment
  • Strategy Development
  • Test Scripts
  • Data Integrity
  • Change Control
  • Corrective And Preventive Action
  • Collaboration
  • Manufacturing
  • Auditing
  • Documentation
  • Computer Science
  • Information Systems
  • Life Sciences
  • Science
  • Training
  • GxP
  • Computerized System Validation
  • Quality Assurance
  • Regulatory Compliance
  • Pharmaceutics
  • Biotechnology
  • Medical Devices

Summary

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 48c374c653d424a05df83a0a3d182c3a
  • Posted 23 hours ago
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