Wayne Beck Email & Phone Number

Tampa, Florida, Us

Generate Project Validation Plan (VPP) and Impact Assessments, IQ, OQ & PQ protocols for New Bulk Chemical Storage and Distribution System (Tank Farm) for Nitrogen, Methylene Chloride, Phosphoric Acid, Caustic Acid, IPA and IPA Waste systems. Generate and execute IOPQ protocols and final reports for modifications to HWFI systems. Generate reports and graphs for viable and non-viable particulate monitoring of clean rooms to qualify the HEPA/HVAC systems.

Cambridge, Massachusetts, Us

Validation Engineer: - ACE Q&C Consulting, contracted to, Merrimack Pharmaceuticals, Cambridge, MAJun 2015 – Aug 2015Generated protocols and performed requalification of loaded chamber temperature mapping on 22 temperature controlled units and 2 warehouse areas, also 2 new units requiring complete IOQ’s.

New York, Ny, Us

Generated and executed IOQ protocols and reports for a new OTC cosmetic product launch.

Germantown, Wisconsin, Us

Preparation & execution of equipment qualification protocols, Preparation of qualification summary reports, Reconciliation of qualification deviations & implementation of CAPA, Implementation of change controls for qualified equipment/systems, Compilation/review of equipment engineering documentation,GMP Procedure (SOP, PM task lists, etc.) revision & preparation.

Author master validation plan and validation documents. Review and approve validation protocols and reports, and the associated equipment SOP’s for operation, maintenance and calibration of the equipment being validated. Assist with the execution of validation studies as necessary, audit validation data and verify that equipment meets acceptance criteria.

Contracted to ACE Consulting for IOPQ preparation and execution for new Cell and Vaccine Production facility prior to phase I clinical trials.

Middlesex, Nj, Us

Current duties include but not limited to;Preparation & execution of equipment qualification protocols,Preparation of qualification summary reports, Reconciliation of qualification deviations & implementation of CAPA,Implementation of change controls for qualified equipment/systems, Compilation/review of equipment engineering documentation,GMP Procedure (SOP, PM task lists, etc.) revision & preparation.

Middlesex, Nj, Us

Writing master validation plans for Air Separation Units (ASU) and Cylinder Fill Facilities. Additional protocols for process and automated fill of LOX & LIN product into transport truck trailers. Writhing Risk Assessment (FMEA) for ASU's & Cylinder Fill facilities. Execution of IOQ & PQ protocols with final reports for existing and new ASU's & Cylinder Fill facilities.

Team member performing Test Methods validation for medical device manufacturing facility.

Wrote protocols for new 220 Standard Tons Per Day Liquid Nitrogen Generator & 200,000 GAL LIN storage tank. Produced IQ, OQ, PQ & Test Method documents, execution of all protocols with final reports.

Team member that assisted in validation effort to bring medical device manufacturing facility into cGMP compliance.

Process validations & discrepancy resolution for new cell culture systems.

Perform temperature mapping and qualification for several cryogenic freezers (-150C) and cold rooms (2-8C) Generate IOQ protocols & Operate Kaye Validator 2000 data logger. Generate final reports with temperature data. Additional equipment validated at this site; Incubators & Wave Bioreactor.

Audit; generate FMEA, Validation protocols, IQ, OQ, & PQ & Test Methods execution and final reports for Air Separation Units that produce Bulk liquid USP Oxygen & NF Nitrogen that comply with GMP & FDA regulations.

Write validation documentation, Risk Assessments, IQ, OQ, PQ and test methods validations.

Mentor, Oh, Us

Education record

Education record

Education record