Validation Engineering Specialist I
Core
Support planning, execution, and documentation of validation activities for Process and Packaging Validation to ensure product quality and regulatory compliance.
Role type
Validation Engineering Specialist
Builds
Validated manufacturing processes and packaging systems for scientific instruments and solutions
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation principles (IQ/OQ/PQ), FDA/EMA regulatory knowledge, statistical analysis, Minitab, GMP manufacturing, documentation, Microsoft Office, risk assessment, data integrity (21 CFR Part 11)
Preferred skills
Cleaning Validation, Continued Process Verification (CPV), Computer System Validation (CSV), Engineering/Chemistry/Biotechnology background
Technologies
Minitab, validation management systems
Responsibilities
Execute validation protocols, maintain quality standards, support continuous improvement, manage multiple priorities
Seniority
Entry-level, hands-on IC
