Commissioning Qualification Validation Engineer
Core
Commission, qualify, and validate GxP facilities, equipment, and utilities to ensure compliance with regulatory requirements and quality standards.
Role type
Commissioning, Qualification, and Validation (CQV) Engineer
Builds
GxP-compliant biotechnology and pharmaceutical manufacturing environments
Domain
Life Sciences / Biotechnology / Pharmaceutical Manufacturing
Required skills
CQV of facility/utility/equipment, GMP compliance, risk-based validation, FAT/SAT execution, IQ/OQ/PQ protocol development, system impact assessment, URS/DS/FS authoring, clean room validation
Preferred skills
None stated
Technologies
HVAC, PW (Pure Water), process equipment, laboratory equipment
Responsibilities
Commission, qualify, and validate GxP facilities, equipment, and utilities; Draft and execute validation documentation (Master Plans, URS, IQ/OQ/PQ protocols, Validation Summary Reports); Initiate and coordinate risk analyses, design reviews, and FAT/SAT; 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
