SENIOR CQV ENGINEER Quality and CQV SME in the Pharmaceutical/Biotech industries. Manage CQV projects for process equipment and utilities installation and qualification. Author, review and approve Lifecycle and change management documents, solid knowledge of QMS tools. Innovative, results oriented team leader and mentor. Work well with cross functional teams and operation personnel
Overview
19
19
years of professional experience
Work History
Sr. CQV Engineer
Greene Group Consulting
08.2021 - 04.2024
Team leader for electronic (paperless) qualification of process equipment, HVAC, CSV and utility systems using ValGenesis validation software
Review and approve protocols, deviations and final reports
Review and approve SOPs
Lead FMEA studies.
Sr. Quality Engineer
Actalent Services
10.2021 - 08.2022
Review executed protocols, deviations and final reports for manufacturing equipment, HVAC, clean and plant utility systems
Lead FMEA studies on USP Purified Water system
Create templates for qualification protocols, final reports to improve consistency across lifecycle documents.
Lead CQV Engineer
Trinity Consulting Engineers
06.2020 - 10.2021
Team leader for the commissioning and qualification of Botox manufacturing system
Equipment train included fermenters, purifications and CIP systems
Write and execute IQ/OQ protocols, resolve deviations and produce final report
Lead CIP and SIP cycle development
Team lead for updating, creating SOPs for a new Drug Substance.
Sr. CQV Engineer
EG Life Sciences
08.2019 - 06.2020
Manage CQV activities for Shenzhen, China facility
Create a validation strategy for Regional Service Centers worldwide
Develop a training program on Validation Best Practices
Responsible for qualifying Device Decontamination procedures.
Filling Lines Process Validation
PSC Biotech
04.2019 - 08.2019
Manage updating activities for Process Specifications and SOPs to an FDA compliant state
Perform SPC, FMEA and Risk Assessment studies
Establish operating parameters of assembly and filling lines to produce consistent product quality
Write, review and execute qualification protocols to confirm operating parameters ranges.
Commissioning and Validation Engineer
Aerotek
10.2018 - 04.2019
Manage CQV activities for the new reagent facility
Write/review IQ/OQ/CSV protocols for utilities, HVAC and process equipment
Supervise and coordinate junior validation engineers’ activities.
Computer System Validation
PSC Biotech
06.2018 - 10.2018
Manage SOP updating activities to ensure compliance to 21 CFR Part11
Identify and remediate gaps in manufacturing Batch Records and manufacturing audit trail
Implement audit trail functionality to equipment control software
Write and execute CSV protocols
Complete CAPA reports, change control, deviation resolution and final reports.
Sr. Project Manager
Vical Incorporated - San Diego, CA
03.2016 - 06.2018
Update quality systems documents to current standards (URS, maintenance and manufacturing SOPs/Batch Records)
Identify and implement Manufacturing Process Improvements for fermentation, Lysis and downstream processes
Write and execute cleaning validation protocols for upgraded upstream manufacturing system
Complete CAPA, FMEA reports, change control, deviation resolution and final reports.
Sr. Project Manager
Pacira Pharmaceuticals - San Diego, CA
01.2014 - 03.2016
Installation of a GMP Cold Room for manufacturing ($500K)
Define scope, resources and budget for the installation of a new GMP cold room for manufacturing
Design, procurement and installation of the cold room
Prepare RFP document for cold room installation, bid analysis and GC selection
Author lifecycle documents, review and approve executed protocols
Author IQ/OQ/CSV for the new cold room
Construction management, startup and qualification
Bulk Chemicals Storage and Distribution Systems (4 MM)
Define scope, resources, and budget with internal cross-functional teams to implement the bulk chemicals storage and distribution systems
Develop VMP and Project Plan for the storage and distribution systems
Produce IQ/OQ/CSV for each chemical system, which included CIP chemicals, IPA, Waste IPA collection and Methylene Chloride
Develop P&IDs for all systems
Develop the sequence of operation and automation strategy, produce Automation Functional Specification
Prepare RFP documents for general contractors, Bid analysis and GC selection
Construction management, start up and validation.
Project Manager
Validation Technologies - San Diego, CA
07.2013 - 01.2014
Prolacta Bioscience – Authored URS, IQ and OQ documents for various processing equipment
Manage validation engineers and client’s technicians during protocol execution
Neutrogena - Los Angeles CA - Lead the upgrade of a fill finish packaging line with high-speed equipment (120 ppm)
Equipment selection, installation and qualification (FAT, IQ/OQ/PQ).
Sr. Project Manager
BioSPEQ - Irvine, CA
02.2011 - 07.2013
Manage teams during execution of validation protocols, author protocols for a variety of processing systems and equipment, business development
TEVA Parenteral: Manage teams during execution of qualification activities of a WFI generation, Storage and Distribution system
Author qualification protocols and Automation Functional Requirements
Gilead Sciences: Commissioning and qualification of an aseptic filling system for a pharmaceutical client in the LA area
The system included vial washers, Depyrogenation tunnel, vial filler and Lyophilizer Auto-Loader
Author commissioning and qualification protocols as well as automation functional specifications
Illumina - San Diego, CA: Produce and execute validation protocols for plant utility systems (N2, E-Generator, CCA), stand-alone fridges and walk-in cold rooms and freezers.
Senior Process and Controls Engineer
Global Automation Partners - Vacaville, CA
07.2005 - 02.2011
Vacaville, Ca
Perform control qualification (CQ) functions on Honeywell's MCS Experion and POMSnet softwareReview and approve software testingStart up of manufacturing systems (CIP, SIP, Upstream, Downstream)
Track software change control
Perform production recipe testing for accuracy and data integrity
Resolve and close deviations encountered during testing
Write Validation Summary Reports for tested systems
Hillsboro, OR
Author IQ and OQ protocols for MCS hardware according to established URS and FS
Author testing protocols for MCS end to end integration to show compliance with CFR21 Part 11
Baxter Biosciences, Glendale, CA – Start up and commissioning of several blood fractioning trains
Equipment included Buffer and precipitation vessels, large volume filter presses and centrifuges.
Senior Geotechnical Engineer at CIVECON Group - Civil Engineering Consulting GroupSenior Geotechnical Engineer at CIVECON Group - Civil Engineering Consulting Group