Commissioning, Qualification & Validation Specialist (CQV)
Core
Support validation activities for equipment, utilities, laboratory systems, and facilities in regulated pharmaceutical, biotechnology, or medical device manufacturing environments.
Role type
Commissioning, Qualification, and Validation (CQV) Specialist
Builds
Validated manufacturing equipment, utilities, laboratory instruments, and cleanroom environments
Domain
Pharmaceutical/Biotechnology/Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, validation lifecycle expertise, IQ/OQ/PQ protocol development, validation documentation authoring, risk assessment, change control support, deviation/CAPA investigation support, Good Documentation Practices (GDP), data integrity principles
Preferred skills
2+ years in validation/commissioning/qualification, technical writing, experience with manufacturing equipment, laboratory instruments, utilities systems, facilities or cleanroom environments
Technologies
IQ/OQ/PQ protocols, validation documentation systems, risk assessment tools
Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols; Assist with equipment startup and commissioning activities; Author and review validation documentation, including protocols, reports, and discrepancy resolutions; Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems; Participate in risk assessments and impact assessments related to validation activities; Support change control, deviations, and CAPA investigations when required
Seniority
Mid-level, hands-on IC
