Validation Engineer
Core
Ensuring compliance of computerized systems across Process Development and Manufacturing through Computer System Validation (CSV) and GAMP methodologies.
Role type
Validation Engineer (Computer Systems Validation)
Builds
Validated computerized systems for pharmaceutical manufacturing and process development.
Domain
Biotechnology / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer Systems Validation (CSV), GAMP 5, SDLC methodologies, ALM testing, Veeva (CDocs, QMS, RIM, DocuSign), 21 CFR Part 11, 21 CFR Part 210/211, IQ/OQ script development, User Requirements Specification (URS), Functional Requirements Specification (FRS), Design Specifications, FDA/EMEA/CFDA regulatory knowledge, risk-based approach, deviation management, test protocol development.
Preferred skills
Microsoft Office suite (Excel, PowerPoint, Visio, Project), Smartsheets, Salesforce, Tableau, FDA audit experience, instrument qualifications, regulated workflows.
Responsibilities
Develop validation documentation and standard operating procedures for GxP applications; develop test protocols to test business requirements; provide test execution oversight and assist with deviation recommendations; work with clients to develop validation plans ensuring GxP compliance; collaborate with business functions and SMEs to develop URS, FRS, and Design Specifications; develop test/validation scripts and IQ/OQ scripts.
Seniority
Mid-to-Senior level (8-14 years total experience required)