Ecocareers ยท 3 days ago
Computer System Validation Engineer
Vacaville, CA
Full-time
Onsite
Mid LevelConfidential company is seeking a Computer System Validation Engineer in the pharmaceutical industry. This role is responsible for ensuring that computer-based systems comply with regulatory requirements such as GxP and FDA standards.
Staffing & Recruiting
Responsibilities
Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports
Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity
Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations
Provide training to stakeholders on validation requirements and best practices
Maintain validation lifecycle documentation and change control records
Qualification
Required
Experience with Computer System Validation (CSV) in a regulated pharmaceutical or biotech environment
Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11
Proficiency in authoring and executing validation documentation
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase