- Experienced quality engineer, results oriented Senior Quality& Validation Expert, experienced in managing diverse teams of technical and non - technical individuals globally to perform computer software and manufacturing validation activities in a regulated global environment. Passion for FDA preparedness and SOP process improvements. Contributions:
- Delivered validation on time and on budget meeting FDA and Security GDPR requirements.
- Managed 15+ years validation leads for Business Systems/IT systems validation meeting internal policies and project methodology, GAMP 1-5, FDA General Principles of Software Validation, Version 1.1.
- Directed PMs within projects in PMM methodology processes delivered to meet business processes. Wrote or reviewed and approved CSV documentation.
- Produced test plans and conducted rigorous testing on projects adhering to companies Standard Operating Procedures and project specifications. Autoclave, Fill lines, EDMS, ERP, SAP systems.
- Expert in Incident, Change, Problem, Incident, SLA, and request management systems HPSM, ServiceNow.
- Managed over 25+ years activities covering quality systems in IT, Manufacturing, Automotive, Automation product testing, working with SCADA (supervisory control data and acquisition).
- Reduction of numerous CSV deliverables by combining Validation Plan and Test Plan.
- Expert trainer: Including CSV for IT, IT Project Management Methodology, and Risk Mgmt. Service Desk and Service Now systems.
- Identifying and assessing risks to business areas and implementing procedures to mitigate negative impacts including business continuity. By following Risk Management delivered 100% to assure systems are without risks, for business continuity. Includes DFMEA, FMEA, and understanding DHF, IQ/OQ/PQ processes lifecycle.
- Acting member 4+ years on BQT for LMS, PMM Change Board, CSV Board, bringing simplification to the processes to achieve accurate results and projects on time.
- Acting advisory of budget decisions for FGSQ supporting the cut of costs.
- Lead the successful completion of Validation of SaaS, PaaS solutions (GxP) with attention to details and removing roadblocks.
- Completed Audit Response and remediation’s of several internal GmP audits for IT Systems
- Lead Audits for internal and external audits to reduce risk and simplify processes, Corrective and Preventive Action, Non-Conformance, OSHA 10. And other safety in IT owned spaces.
- Validated and Designed, automation production equipment for alternators and starters to increase lean cell design throughput to 120%.
Sr. validation engineer consultant
- Creation of Validation packages for: Fill lines, QC Equipment, Spectrophotometers, UPLC, HPLCs, LIMS, Manufacturing: Fermentation, vail capping, autoclaves, etc.
- Guidance over computer system validation and other supporting IT processes.
- Lead validation efforts; for local systems Agile (Oracle PLM), EtQ, Bridge, LabVantage, LIMS, Bottle Fill, RFID barcode Labeling.
- Expert Super User: EDM solutions, PLM Agile, SAP solutions, ProE, AutoCad, SolidWorks, and Microsoft Office.
- Experiences: LavVantage, SAP LIMS, developing and testing software using the latest life cycle management tools to create URS, FRS, OQ, and PQ among other details like System Risk Assessments, FMEA, Validation Plans.
- Project lead: validation for CSV, Pharmaceutical, Medical Device, Life Science computer systems.
Confidential, Indianapolis, IN
Sr. (PrincipaL) Lead IT Quality & Validation expert
- Advising member of BQT Business Quality Team (Board) for Learning Solution Global Business Quality heads and am liaison to IT Quality membership includes Pharma, Diagnostics, PRed, gRed, Genentech head quality members.
- Manage indirectly validation engineers Site Basel, LSO, Cornerstone, packaging & distribution systems, Mobile apps, engineering drawing repository systems. Testing of Mobile application for Cornerstone pilot using Worksoft and HPQC ALM.
- Advising member of PMM Project Management Methodology Board for process changes.
- Learning expert for IT Trainings, CSV, PMM, PMO Agile
Confidential, Indianapolis, IN
Sr. It Quality Consultant /Analyst
- Directed IT business application teams in validation of critical software applications using the Project Methodology and CSV guidelines, procedures, and policies. Applications included SAP (Manufacturing, Logistics, Service), ELN, MES, Freezer Works, Automated Worksoft, Cornerstone, LSO, HPQC ALM, iLSO Mobile application for learning, facilitated system risk assessments to determine regulatory, business, technical risk and identify mitigating action items.
- Directed system and user acceptance testing efforts to determine that user requirements were met and objective results were documented properly.
- Lead disaster recovery testing to ensure critical applications could be restored to the productive environment with minimal downtime to business areas.
- Supported teams: Validations for process Diagnostic Medical Devices, Clean Room, Autoclave sterilization and other instruments.