SUMMARY:

• Remediated non - conformances, deviations and change controls in a commercial manufacturing environment (Trackwise)
• Developed Supplier Quality Program
• Internal Department Audits to prepare for FDA inspections
• Managed CAPA system and mitigated over 500 non-conformances for using Trackwise Software.
• Managed Customer Complaints Department
• Delta V Validation
• Validated Calibration Systems (Maximo)
• Product Characterization, Design and Equipment Qualification (PPQ)
• Continuous Process Verification/Monitoring
• CIP/SIP programs to validate cleaning processes.
• Bioreactor and skid validation.
• COP of small parts and ancillary components.
• Labelers, Cartoners, Vision System, WFI, Aseptic Tanks, CIP/SIP Skids, Hata Tablet Press, Check Weigher, Glatts, Micro Fluidizers and Fermenters
• ASTM E2500: DQSA (Serialization Guidance); FDA PV 2011
• Drafted URS, FS, DS, DQ RA, CA, IQ OQ, PQ and Summary Reports
• Drafted VMP’s and SOP’s
• Development of testing procedures and validation of methods in accordance with ICH guidance’s and .Industry Standards
• Expertise in usage of data loggers for temperature and humidity monitoring.

TECHNICAL SKILLS:

Proficient in: Word, Excel, Microsoft Project, Power Point, Technical Writing

EXPERIENCE:

Confidential, Irvine, CA

Project Manager

Responsibilities:

• Validation of Deacom ERP Inventory Management Module (CSV)
• Validation of IMA Lyophilizer and Bosch Dry Heat Tunnel Qualification

Confidential, St Louis, MO

Process Validation Mgr.

Responsibilities:

• Revised existing PV SOP to align with FDA, EMA and other regulatory agencies based on the 2011 Process Validation Guidance
• Developed templates for each phase of the process validation lifecycle.
• Trained entry level PV staff on process validation
• Assisted with all client process validation programs
• Customer Calls
• Review of all protocols
• Assist with mfg. executions as required
• Drafted Process Validation Policy and Program for existing sites (NJ, Netherlands, Australia and St Louis)

Confidential, CA

Project Manager

Responsibilities:

• Validated PLC upgrade to New DeltaV Control System
• Drafted URS, FS, DS and IOPQ for customized fermenters
• Qualified Bioreactor Train 80L-12K using new automated Delta V system

Confidential, Port Washington, NY

Senior Manager

Responsibilities:

• Managed North/South American Filter Validation Services
• Work directly with sales to grow business up to 20% each year.
• Manage SLS budgets and personnel
• Validated new CIP/SIP skid for existing and new product lines
• Validated New Calibration program (Maximo)
• Drafted, executed and summarized qualification and validation protocols for manufacturing equipment. (Fermenters and CIP/SIP Skid)
• Validated CSV spreadsheets used in Quality Control to release commercial product.

Confidential

Regional Manager

Responsibilities:

• Managed 15+ employees at various biotech/pharma companies throughout the north east region
• Managed regional budgets
• Generation of Validation Project proposals
• Employee Staffing for entire Northeast Region
• Remained 30% billable at multiple client sites
• Managed Validation Team of 4-6 Engineers.

Validation Project Manager

Confidential, Milford, MA

Responsibilities:

• Validation Program Upgrade
• Update VMP
• Revise IOPQ Templates
• Create Validation Steering Committee
• Update Equipment List and Validation Schedule
• Institute New Thermal Mapping Program

Validation Project Manager

Confidential, Hopkinton, MA

Responsibilities:

• Remediation of deviations/non-conformances and CAPA’s for Multiple Contract Clients
• Commercial Manufacturing, QC deviations, Facilities Manufacturing
• Batch Record Review and QA Lot Release

Confidential, Lincoln, Nebraska

Validation Project Manager

Responsibilities:

• Manage Packaging Line Remediation
• Serialized OTC Products Lines
• Creation of Site Validation Program
• Re-qualification of Labelers, Cartoners and Vision System

Confidential, Framingham, MA

Validation Project Manager

Responsibilities:

• Re-Qualification of process equipment. CIP Tanks & Skids, SIP of Bioreactors, drain lines, feed tanks, autoclaves, COP of small parts and ancillary equipment.

Confidential, Parsippany, NJ

Manager of Quality Systems

Responsibilities:

• Managed Quality Systems.
• CAPA Program,
• Customer Complaints,
• Internal Audits Department
• Supplier Quality Program
• Change Control
• Managed Validation Program:
• Packaging Validation: Vision System. Labelers
• Cleaning Validation: Aseptic Tanks
• Equipment Validation (IQ,OQ, & PQ Drafting)
• Validation Master Plan/Schedule development and maintenance
• Consolidation and revalidation of laboratory equipment.
• Write, execute and summarize all qualification protocols for equipment.
• Qualification/execution of IOQ protocols for forty eight (48) refrigerators and freezers in the GMP Stability and Research facilities using thermal mapping technique

Confidential, Kenilworth, New Jersey

Senior Engineer

Responsibilities:

• Supervised 6-10 qualification engineers in compliance projects outlined in Confidential
• Remediation of CAPA’s, Deviations/Non-Conformances in conjunction with Confidential
• Utilities and Laboratory Equipment: Autoclaves, Ovens, Incubators, Freezers, WFI, Compressed Gases & HVAC systems: (Temperature Mapping using Kaye Validator 2000)
• Cleaning Validation: CIP/SIP of Bioreactors and transfer lines; COP of small part and ancillary components/equipment; Swabbing procedure development. Qualification of TOC Analyzer. Delta V parameter development for CIP/SIP skids
• Packaging/Manufacturing Equipment Qualification: (i.e. Hata Tablet Press; Check Weigher; Glatt Fluid Bed Control System; Distribution Pumps)

Confidential, Hilltown, PA

Project Lead

Responsibilities:

• Equipment validation of autoclaves, Ovens, Incubators, Freezers, WFI, Compressed Gases & HVAC systems (Temperature mapping using Kaye Validator 2000)
• Qualification of Parts Washer and Validation of COP for small parts and ancillary components.