Infiligence Inc ยท 1 day ago
Life Science - V&V specialist (Pleasanton)
Pleasanton, CA
Full-time
Hybrid
Senior Level
5+ years expInfiligence is a specialized technology services firm serving the life sciences industry. The role involves leading validation initiatives, ensuring regulatory compliance, and supporting quality and compliance functions for a range of life science clients.
BankingFinTechLife ScienceMedia and Entertainment
No H1B
Responsibilities
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
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)
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
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
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
Qualification
Required
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
Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Systems, or related field
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
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
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
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
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
Benefits
Work-life integration and flexibility
Investment in your professional growth
Diversity, equity, and inclusion commitment
Company
Infiligence Inc
Platform Engineering Company
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase