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Network Power<100 people
Roles
🧨100%
Consulting
🧮100%
Education
💰50%
Investor & VC
Geos
🇺🇸50%
United States
Work Background
Valspec Lead Validation Engineer
Sep. 2024Holly Springs, North Carolina, United StatesNew plant build out! My favorite! Let's go!
Excellis Health Solutions - An NNIT Group CompanySenior Consultant
May. 2022 - Jul. 2024Philadelphia, PALaid off in July 2024 as part of company reduction in force. It happens to the best of us! Amgen, Inc. | Thousand Oaks, CA (Remote)
Site Account Lead: Grew account 10x to over $750K in 18 months. Expanded team size and managed client relationships. Developed key project deliverables and managed all team accounting functions.
GLAM-DTI (Global Lifecycle Asset Management - Digital, Technology, and Innovation): Delivered 7 projects with 3 ongoing. Upgraded PLC automation systems, FactoryTalk AssetCentre, and DeltaV systems. Managed deliverables and test execution for three subcontractor teams. Fostered strong relationships with portfolio and project management, securing repeat work for three years and expanding the role to include GCPM.
GCPM (Global Capital Projects Management): Completed 4 projects with 1 ongoing. Led the installation of Clean-in-Place skids and a Centrifuge. Coordinated deliverable generation and test execution with OEMs, subcontractors, and Amgen FTEs. Built lasting relationships with Amgen FTEs in Facilities & Engineering, leading to expanded roles.
VeristaValidation SME / Project Manager
Oct. 2021 - Mar. 2022Boston, MARemote project management and computer system validation support for pharmaceutical clients.
EG Life SciencesSenior CSV Engineering Consultant
Jan. 2021 - Sep. 2021Greater HoustonClient: Catalent, Houston TX Led Computer Systems Validation for a new cell/gene therapy facility.
Developed SOPs and templates for CSV, managing timelines and deliverables.
Oscor Inc.Senior Validation and Compliance Engineer
Aug. 2017 - Jan. 2021Palm Harbor, FloridaSubject Matter Expert for remediation of validation and compliance activities at a dynamic and innovative medical device manufacturing firm.
VistaPharm, IncValidation Specialist
Apr. 2016 - Aug. 2017Largo, FLValidation Lead for CMO firm.
Managed commitments for five concurrent capital projects.
Coordinated remediation activities for compounding equipment and facilities.
Revised SOPs and developed remediation plans for all equipment and processes.
Barry-Wehmiller Design GroupValidation Engineer
May. 2014 - Mar. 2016Columbus, OhioClient: Boehringer-Ingelheim Roxane Labs, Columbus, OH Led validation for packaging serialization project.
Managed multiple validation projects and mentored junior team members
E-Technologies GroupLead Validation Engineer
Sep. 2011 - Jan. 2014West Chester, Ohio, United StatesValidation team lead for Fortune 500 client OTC manufacturing automation project
• Developed URS, VMP, Risk Assessment, FAT, SAT, IQ, and OQ
• Developed innovative method of dividing IQ and OQ into remote and local execution phases to best accommodate client project schedule and budget Validation team lead for Fortune 500 client liquid nutrition manufacturing capacity upgrade project
• Two year project with multiple shutdown periods, leading teams in 24 hour site support
• Coordinating the development and execution of all risk-based validation documents (IQ, OQ, PQ) with multiple client and contractor teams Technical lead for client startup medical device manufacturing project
• Designed overall product design, manufacturing, and validation phases for multi-year startup
• Designed and performed experiments to assist client in material selection for product
• Developed initial corporate SOPs to govern client processes Developed and delivered internal team training courses on 21 CFR 11, validation scope definition, and process evaluation within the integrated project lifecycle.
DSMValidation Consultant
Dec. 2010 - Aug. 2011Greenville, North Carolina1099 Contractor through Soliance Services / Emergo Group Led medical device manufacturing technology transfer capital project.
Established quality monitoring and risk management programs.
JacobsCommissioning/Qualification/Validation Engineer
Feb. 2008 - Jul. 2010Indianapolis, IndianaConsultant Engineer established on site at Eli Lilly and Company. Projects: Installation of four HVAC units, installation of a containment manufacturing suite, replacement of a compressed gas distribution system, and conversion of two underutilized spaces into GMP storage facilities
• Managed schedule and budget for validation and other documentation aspects of projects
• Wrote SOPs and training modules for use of new HVAC units and gas distribution system
• Trained team members on use of validation testing equipment and procedures Quality activities:
• Development and execution of qualification and validation protocols (IQ, OQ, PQ, CSV)
• CAPA change and event management author, lead investigator, and metrics evaluator
• Managing closure of internal and external audit observations
• Evaluation of process problems and use of statistical analysis to improve process control
• Performance of annual Quality evaluations including sampling data analysis for clean utilities
• Revision of engineering drawings and procedures to accurately reflect current best practices and field status
Performance ValidationValidation Engineer
Jun. 2003 - Jan. 2008Indianapolis, IndianaCommissioning, qualification, validation, and operational support activities for manufacturing of oral solid dosage products, parenteral products, biotech products, and medical devices.
Smith & NephewValidation Associate / Sales and Marketing Assistant
Jun. 2002 - Feb. 2003Largo, Florida4 months in Sales/Marketing for Transcyte and Dermagraft
---Contributed to development of Preceptor program for Dermagraft 4 months in Engineering
---Performed validation work on Largo, FL facility expansion
---Qualification / Validation of facility, utilities, equipment, and computer control system
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