CQV Engineer II
Core
Ensuring systems, facilities, and equipment meet design requirements for facility commissioning and qualification to maintain product integrity and enable growth.
Role type
Senior IC CQV Engineer
Builds
Commissioned, qualified, and validated facilities, utilities, and equipment
Domain
Biomedical and pharmaceuticals industry
Required skills
CQV technical execution, DQ/FAT/SAT/IQ/OQ/PQ/PV document authoring, SOP development, cGMP compliance, data integrity guidelines, risk analysis, design reviews, project timeline management, vendor/contractor coordination, strategic thinking, analytical skills
Preferred skills
Mentoring, relationship building, negotiation, rational persuasion, agility, multi-tasking
Technologies
GMP, GDP, cGMPs, Data Integrity guidelines
Responsibilities
Commission, qualify, and validate facilities, utilities, and equipment; initiate and coordinate risk analyses, design reviews, FAT/SAT, IQ, OQ, and PQ; author, revise, and review controlled documents and technical specifications; develop SOPs and final reports; manage project activities and timelines; provide status reports to Project Manager; mentor client and local teams
Seniority
Mid-Senior, hands-on IC
