CQV Engineer
Core
Execute qualification protocols (IQ/OQ/PQ) and manage validation documentation for life sciences equipment and processes.
Role type
CQV Engineer
Builds
Validated equipment and processes for drug manufacturing
Domain
Life sciences / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV and temperature mapping, FDA/ICH/ISPE/ISO guidelines, deviation management, risk identification, protocol writing, equipment troubleshooting
Preferred skills
Engineering degree, Microsoft Word/Excel proficiency, cross-functional collaboration
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
