Job Description
Computer System Validation (CSV) Specialist
Infiligence - Pleasanton, California (San Francisco Bay Area)
About Infiligence
Infiligence is a specialized technology services firm serving the life sciences industry. We partner with digital health innovators, biotech companies, pharmaceutical manufacturers, and medical device firms to deliver compliant, scalable technology solutions. Our expertise spans DevOps for regulated environments, legacy modernization, Computer System Validation/Quality Engineering, and healthcare interoperability.
The Opportunity
Join our Bay Area validation practice supporting an impressive portfolio of life science clients-from Series B digital health startups to Fortune 500 pharmaceutical companies. Based in Pleasanton with proximity to the thriving Bay Area biotech corridor, you'll work on cutting-edge systems while ensuring rigorous regulatory compliance.
What You'll Do
Lead Validation Initiatives
- Execute comprehensive computer system validation (CSV) activities across the validation lifecycle
- Author and review validation documentation: Validation Plans, URS, Functional/Design Specs, Risk Assessments, Traceability Matrices, and IQ/OQ/PQ protocols
- Apply GAMP 5 risk-based validation methodologies to categorize systems and determine appropriate validation rigor
- Validate diverse systems including cloud-based SaaS platforms, on-premise enterprise applications, and hybrid architectures
Ensure Regulatory Compliance
- Maintain strict adherence to FDA 21 CFR Part 11, GxP (GMP, GCP, GLP, GVP), EU Annex 11, and GAMP 5 requirements
- Implement data integrity (ALCOA+) controls and electronic signature/audit trail requirements
- Perform gap analyses against regulatory standards and develop remediation roadmaps
- Stay current on evolving FDA guidance (e.g., Computer Software Assurance, Digital Health Software Precertification)
Support Quality & Compliance Functions
- Provide validation expertise during FDA inspections, internal audits, and client/vendor audits
- Prepare validation summary packages for regulatory submissions (510(k), NDA, BLA)
- Support CAPA investigations and change control processes
- Review supplier CSV documentation and conduct vendor qualification audits
Drive Innovation & Continuous Improvement
- Champion modern validation approaches: Continuous Validation, Agile Validation, DevOps in regulated environments
- Collaborate with DevOps and QE teams to integrate automated testing into validation strategies
- Mentor junior validation professionals and contribute to practice development
- Support business development with validation assessments and scoping
Client Partnership
- Serve as trusted validation advisor to client Quality, IT, Regulatory, and Engineering teams
- Communicate complex validation concepts to both technical and non-technical stakeholders
- Manage validation project timelines, budgets, and deliverables
Required Qualifications
Experience
- 5+ years of hands-on CSV experience in FDA-regulated life sciences environments (pharmaceutical, biotech, medical device, digital health)
- Proven delivery of validation projects from planning through execution and closeout
- Experience across multiple systems and platforms (see Technical Expertise below)
Education
- Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Systems, or related field
- Advanced degree (MS, MBA) is a plus
Technical Expertise
- Expert-level knowledge of GAMP 5 (all categories, risk-based validation, Agile/DevOps approaches)
- Deep understanding of FDA 21 CFR Part 11, GxP regulations, EU Annex 11, and data integrity requirements
- Hands-on validation experience with systems such as:
- Quality & Regulatory : Veeva Vault QMS/RIM, MasterControl, TrackWise, eCTD submission tools
- Clinical : EDC (Medidata Rave, Oracle Clinical), CTMS, eTMF, IVR/RTSM, Safety databases
- Manufacturing/Lab : LIMS, MES, SCADA, SAP ERP, batch management systems
- Commercial : Salesforce CRM, Veeva CRM
- Digital Health : Mobile medical apps, SaMD platforms, patient-facing applications
- Cloud Platforms : AWS, Azure, GCP (validation of cloud infrastructure and SaaS)
Core Competencies
- Outstanding technical writing skills with ability to create clear, audit-ready documentation
- Strong analytical and critical thinking abilities
- Excellent attention to detail and organizational skills
- Effective stakeholder management and communication (executive to end-user)
- Self-motivated with ability to work independently and collaboratively
- Comfortable managing multiple concurrent projects in fast-paced environment
Preferred Qualifications
Advanced Experience
- Cloud-native validation (containerization, microservices, serverless architectures)
- Agile validation and Continuous Validation methodologies
- Computer Software Assurance (CSA) per FDA draft guidance
- Medical device software (IEC 62304, ISO 13485, ISO 14971)
- Digital therapeutics (DTx) and Software as a Medical Device (SaMD)
- Experience with AI/ML validation frameworks (FDA AI/ML guidance)
- DevSecOps integration with validation processes
Certifications & Professional Development
- ISPE member or certified
- RAPS (RAC - Regulatory Affairs Certification)
- ASQ (CSQE - Certified Software Quality Engineer or CQE)
- PMP or similar project management certification
- ITIL Foundation or above
Industry Experience
- Startup/scale-up digital health environment (Series A-D)
- Big Pharma or Top 20 biopharma experience
- Medical device Class II/III experience
- CRO or CDMO validation experience
Career Path
Clear progression: CSV Specialist Senior CSV Specialist Validation Lead Practice Manager Director of Quality Engineering
Work Environment & Location
Office Location
- Pleasanton, California - Bay Area (East Bay)
- Modern office space with collaboration areas
- Proximity to major life science hubs: South San Francisco, Emeryville, Berkeley, Fremont
Work Model
- Hybrid : 2-3 days/week in Pleasanton office (flexible based on project needs)
- Remote work options for experienced hires
- Occasional client site visits in Bay Area and beyond
Why Join Infiligence?
Work That Matters
- Directly impact patient safety and drug/device quality
- Enable life science innovation through compliant technology
- Diverse project portfolio from digital health disruptors to established pharma
Bay Area Life Science Ecosystem
- Access to the world's densest concentration of biotech, digital health, and pharma innovation
- Network with leading life science professionals
- Stay at forefront of regulatory and technology trends
Growth-Stage Company Benefits
- Meaningful impact on company direction and practice development
- Entrepreneurial environment with enterprise-client exposure
- Build long-term client relationships and technical reputation
Culture
- Collaborative, quality-focused team
- Work-life integration and flexibility
- Investment in your professional growth
- Diversity, equity, and inclusion commitment
Application Instructions
Please submit your resume with the information below:
- Resume highlighting validation projects, systems validated, and regulatory frameworks
- Specific systems validated, validation documentation authored, and any FDA inspection or audit support experience.
Infiligence is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Tags
Work at office, Remote work, Flexible hours, 2 days per week, 3 days per week,