Vickie Burrie
Buckeye,AZ
Summary
Intelligent and qualified Validation Engineer with extensive experience assessing software systems for alignment with specifications and project goals. Talented at documenting and reporting for accurate recordkeeping. Enthusiastic professional with focus on effectively analyzing test results.
Overview
30
30
years of professional experience
Work History
Validation Engineer
Axis Consulting, Inc.
10.2014 - Current
- Responsible for client site validation of Vaisala viewLinc Continuous Monitoring System
- Execution of all aspects of monitoring software IQs and OQs
- Successfully interface with customers at various levels of GMP, predominately pharmaceutical
- Work closely with client quality and IT teams to ensure all systems meet requirements for qualification
- Utilize intense time-management skills to complete jobs with limited time, troubleshoot diverse implementation and execution concerns
- Author and execute performance and operational qualifications for analytical and manufacturing equipment at Kulira Technologies in Peoria, AZ.
Validation Engineer
Halcyon Consulting, Inc
03.2017 - 07.2021
- Responsible for writing and executing validation protocols for various production equipment and controlled temperature and humidity chambers.
Purchasing Manager
Zosano Pharma Corporation
01.2009 - 08.2014
- Oversee procurement and receipt of all goods and services for a large-scale R&D pharmaceutical company
- Create all purchasing polices
- Hire, train and manage a team of buyers
- Approve and edit other buyers’ requisitions and purchase orders
- Establish new supplier accounts, negotiate contracts and discount pricing agreements
- Frequently meet with key suppliers to ensure competitive pricing and timely deliveries
- Participate in strategic supplier audits, create and maintain GMP approved supplier database and write or approve all purchasing SOPs
- Work with manufacturing and supply chain to maintain adequate inventory levels for production
- Administrate purchasing program software and train all Zosano personnel in requisitioning and purchasing
- Assist CFO in assessing and presenting Cost of Goods Sold.
Project Manager
TMIV, a J&J Subsidiary
08.2005 - 01.2009
- Project management of $22MM manufacturing facility comprised of existing building renovation, new construction, custom manufacturing equipment, lab space and equipment, gowning areas and warehouse storage space
- Integral part of various commissioning teams that install and validate new equipment purchases
- This included ERP database, GMP sterile coater, custom forming and assembly machines and facility IOQ projects
- Participate in vendor selection
- Initiate and write RFPs necessary for one-off custom aseptic manufacturing equipment
- Assist with URS/FRS document creation and other related commissioning documentation
- Work closely with Finance department to calculate fixed asset values for depreciation
- Responsible for tracking tenant improvement allowance, successfully submitting and receiving $16MM in reimbursement requests from facility owner.
Business Owner and Director
Pacific-Bios
01.1999 - 01.2009
- Successful management of pharmaceutical consulting firm
- Responsible for accounting, recruiting, training, marketing, benefit and payroll functions, including estimating, project tracking, invoicing, and all federal and state tax reporting
- Responsible for bidding and managing proposals for a team of validation and regulatory consultants
- Oversee personnel conducting GMP operations
- Knowledgeable about GDP and reviewing validation documentation for pharmaceutical operations and sterile manufacturing
- Write and/or approve all corporate policy documents, standard operating procedures, legal agreements, and sales orders
- Manage teams of employees and subcontractors at various client sites.
Engineering Development and Validation Project Manager
Johnson & Johnson
05.2000 - 08.2005
- Manage timelines, budgets, materials acquisition and installation for various multi-million dollar manufacturing projects
- Ensure on-time completion for design and engineering, fabrication of system components
- Assist with equipment installation, commissioning, and validation after delivery to Alza/J&J, including execution of FAT and IOQ for custom tablet laser-driller, IOQ and temperature mapping for drying ovens, facility IOQ and sterile gowning PQ
- Conduct FMEA writing for new equipment
- Provide upper management with weekly progress timelines and monthly budget variance reports
- Responsible for setting up accounts and executing contracts for new vendors
- Recent assignments include successful project management assistance for fabrication/installation of $26MM pilot facility for both transdermal and implantable devices
- Ensure functional/user requirement documents are written and prepared for new equipment purchases.
Validation Coordinator
Alza Corporation
01.1999 - 05.2000
- Assist with equipment validations for new sterile fill facility, including execution of autoclave IOQs, autoclave load configurations, Hamo washer IOQs and PQs, shaker IOQs, oven IOQs, oven temperature mapping and lab cold storage IOQs and PQs
- Create an extensive accounting and budgeting database for better budget control
- Maintain this database in conjunction with preparing 1999 and 2000 budgets
- Responsible for all validation invoice processing and accounts payable
- Active role in project tracking, creating timelines and organizational reports
- Responsible for maintaining a database of validation protocols, assigning protocol numbers, acquiring approval signatures, tracking protocol status, and filing/locating all validation documents
- Assist in preparing for FDA audit.
Restaurant Manager
Fresh Choice Restaurants
01.1995 - 10.1998
- Manage and direct the operations of a 55-employee restaurant
- Responsible for full-scale food orders and weekly food inventory
- Successfully implement program for reducing food costs
- Provide scheduling for all employees and successfully reduce monthly labor costs
- Responsible for interviewing and hiring for all positions, conducting new employee orientations, extensive employee training and performance reviews
- Select, review and manage various outside vendors, negotiating supply and service contracts
- Perform monthly P&L analysis and account for any discrepancies.
Education
Bachelors of Science in Business Management - Marketing
Brigham Young University
Provo, UTSkills
- Process Analysis
- Effective Communication
- Math Skills
- Quality Management Systems
- Validation Protocols
- Data Integrity
- Process Validation
- Interpersonal Skills
- Written Communication
Training
- 2020, Vaisala 5.1 Continuous Monitoring System Validation Training
- 2018, Vaisala Continuous Monitoring System Validation Training (5.0)
- 2015, Vaisala Continuous Monitoring System Validation Training (4.3)
- 2015, Pharmaceuticals – Principles of Good Documentation Training Course
- 2013, GMP Training, Zosano Pharma
- 2010, GMP Training, Zosano Pharma
- 2009, GMP Training, Zosano Pharma
- 2005, Maintenance Excellence Certification, Johnson & Johnson
- 2004, GMP Training, Alza Corporation
- 2003, GMP Training, Alza Corporation
- 2000, GMP Training, Alza Corporation
- 2004, Charter Member Toastmasters, Johnson & Johnson
- 2000, Advanced Excel Certification, Alza Corporation
Timeline
Validation Engineer
Halcyon Consulting, Inc
03.2017 - 07.2021
Validation Engineer
Axis Consulting, Inc.
10.2014 - Current
Purchasing Manager
Zosano Pharma Corporation
01.2009 - 08.2014
Project Manager
TMIV, a J&J Subsidiary
08.2005 - 01.2009
Engineering Development and Validation Project Manager
Johnson & Johnson
05.2000 - 08.2005
Business Owner and Director
Pacific-Bios
01.1999 - 01.2009
Validation Coordinator
Alza Corporation
01.1999 - 05.2000
Restaurant Manager
Fresh Choice Restaurants
01.1995 - 10.1998
Bachelors of Science in Business Management - Marketing
Brigham Young University
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