Validation Engineer
Core
Prepare, review, and execute commissioning, qualification, and validation documents for processes, materials, equipment, cleaning, and computerized systems/software in a cGMP regulated manufacturing environment.
Role type
Validation Engineer
Builds
Validated manufacturing processes, equipment, and computerized systems for life-changing therapies
Domain
Biopharmaceutical manufacturing / Quality Assurance
Required skills
cGMP compliance, process validation, equipment qualification, computerized system validation, risk assessment, deviation management, CAPA preparation, root cause analysis, engineering logic
Preferred skills
Material qualification, regulated industry experience, Microsoft Office proficiency
Responsibilities
Support GMP Impact Assessments, User Requirement Specifications, Traceability Matrices, and Design Qualifications; Execute engineering pre-validation studies; Troubleshoot process issues and resolve deviations/non-conformances; Prepare change controls and investigations
Seniority
Mid-level, hands-on IC
