Commissioning Qualification Validation Engineer
Core
Commission, qualify, and validate GxP facilities, equipment, and utilities for biotechnology and pharmaceutical clients.
Role type
Commissioning, Qualification, and Validation (CQV) Engineer
Builds
GxP-compliant facilities, equipment, and utilities
Domain
Biotechnology and Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV of facility/utility/equipment, risk-based validation approaches, GMP and PIC/S code knowledge, system impact assessment, risk assessment, authoring controlled validation documents, FAT/SAT/IQ/OQ/PQ execution
Preferred skills
process improvement, performance testing, quality control measures
Technologies
HVAC, PW, process equipment, laboratory equipment
Responsibilities
Commission, qualify, and validate GxP facilities, equipment, and utilities; Draft and execute validation documentation (Master Plans, URS, DS, FS, IQ/OQ/PQ Protocols, Validation Summary Report); Initiate and coordinate risk analyses, design reviews, and FAT/SAT/IQ/OQ/PQ; Conduct preventative maintenance and perform risk assessments; Establish validation standards and develop performance testing and quality control measures; Execute process equipment and clean room validation.
Seniority
Mid-level, hands-on IC
