CQV Engineer
Core
Execute qualification protocols (IQ/OQ/PQ) and temperature mapping to ensure equipment and processes meet FDA/cGMP standards for drug manufacturing.
Role type
CQV Engineer (Validation & Qualification)
Builds
Validated manufacturing equipment, processes, and systems for life sciences clients
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV protocols, temperature mapping, IQ/OQ/PQ execution, deviation management, risk mitigation, FDA/cGMP compliance, documentation generation
Preferred skills
Engineering degree, cross-functional collaboration, problem-solving
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Write, review, and execute qualification protocols (IQ/OQ/PQ) for new and existing equipment; Troubleshoot and improve equipment, processes, and systems; Identify risks to product quality and apply mitigation strategies; Generate validation reports and maintain compliant documentation following FDA and cGMP guidelines; Manage and close deviations or non-conformances identified during testing; Support engineering documentation such as user requirements and design qualification materials
