Computer System Validation (CSV) Engineer

Primary Location – San Francisco, California (On-site)

Solios Corp is currently hiring for a Computer System Validation (CSV) Engineer to support our client’s regulated healthcare and diagnostics environment. This is a full-time, permanent position with Solios Corp.

WHAT YOU’LL NEED:

Technical Requirements and Certifications »

• Strong understanding of GxP regulations (GLP, GMP, GCP) and 21 CFR Part 11 compliance
• Experience validating computerized systems such as LIMS, ERP, SCADA, and other lab/manufacturing applications
• Familiarity with validation lifecycle documentation including URS, FRS, IQ, OQ, PQ
• Knowledge of risk-based validation approaches and data integrity principles
• Understanding of FDA, EMA, and other global regulatory requirements

Education and Experience »

• Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field
• 5+ years of experience in CSV within pharmaceutical, biotech, diagnostics, or healthcare industries
• Hands-on experience with electronic validation tools and documentation systems
• Experience working in audit-ready environments subject to FDA or CAP/CLIA inspections

Preferred Qualifications »

• Experience validating SaaS or cloud-based healthcare applications
• Working knowledge of ALCOA+ principles for data integrity
• Background in lab automation systems or manufacturing execution systems (MES)
• Familiarity with CAPA, change control, and deviation management processes
• Understanding of Agile or hybrid SDLC/CSV environments

Knowledge, Skills and Abilities »

• Excellent documentation and analytical skills
• Ability to communicate technical content clearly across cross-functional teams
• Strong attention to detail and organizational skills
• Problem-solving mindset with a focus on regulatory compliance
• Proficiency in tools such as TrackWise, MasterControl, or Veeva

Competencies:

• Regulatory Compliance
• Computer System Validation
• Risk Management
• GxP Practices
• Audit Preparedness
• Documentation Excellence

WHAT YOU’LL DO:

Job Responsibilities »

• Lead the planning, development, execution, and documentation of validation activities for healthcare IT systems
• Ensure all computer systems meet applicable regulatory requirements and internal quality standards
• Develop and maintain validation deliverables such as validation plans, protocols, traceability matrices, and reports
• Collaborate with QA, IT, lab operations, and vendors to ensure compliant system implementation
• Support periodic reviews, system change requests, and re-validation efforts as needed
• Prepare systems and documentation for internal and external audits, ensuring inspection readiness
• Provide training and guidance on CSV principles, procedures, and documentation standards
• Participate in risk assessments and gap analyses to identify areas of improvement or non-compliance
• Maintain validation status tracking and ensure timely execution of validation tasks

Contribute to the continuous improvement of validation processes and templates