Angel Steinkellner

Project Manager Lead Cqv Engineer @Verista

Project Manager/Lead CQV Engineer - Analytical Services • Project Manager for Capex projects • Change Control SME for analytical lab equipment • Computer System Validation (CSV) Project Manager/Lead CQV Engineer – Cleaning Validation • Project Manager and Validation Lead for Cleaning Validation at a large-scale pre-filled syringe manufacturing facility• Developed overall strategy, authored, and executed all Cleaning Validation activities on multiple Parts Washers• Executed Autoclave Validation on multiple autoclaves• Lead multiple investigations and authored deviation reports with corrective actions• Identified process gaps and worked on making changes for continuous improvement• Authored multiple interim and final summary reports for validation activities to support ongoing needs for site start-up• Revised/technically reviewed multiple SOPs • Experience with Kneat (End User Certified), Veeva, Trackwise, and Darwin• Trained and mentored several junior team membersSenior CQV Engineer • Authored multiple validation documents for client site– URS, IQ, OQ, PQ protocols and reports• Temperature & Humidity Mapping – authored protocols and reports for entire site & provided guidance to team members and client