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 (Lonza Biologics, Confidential (Medical Device) & Merck-Pharma) using Trackwise Software.
• Managed Customer Complaints Department
• 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.

TECHNICAL SKILLS:

Technology and Tools: Proficient in Word, Excel, Microsoft Project, Power Point, Technical Writing: Quality System Certified: AAMI (Association for the Advancement of Medical Instrumentation): Certified in Thermal Mapping: Kaye

PROFESSIONAL EXPERIENCE:

Project Manager

Confidential - Irvine, CA

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

Confidential, SSF, 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, NY

Senior Manager

Responsibilities:

• Work directly with sales to grow business up to 20% each year.
• Manage SLS (Scientific Laboratory Services) budgets and personnel (Approximately 30 employees)

Confidential -Framingham, MA

Independent Consultant

Responsibilities:

• 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

North East Regional Manager

Responsibilities:

• 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.

Confidential -Milford, MA

Validation Project Manager

Responsibilities:

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

Confidential -Hopkinton MA

Validation Project Manager

Responsibilities:

• Remediation of deviations/non-conformances and CAPA’s for Multiple Contract Clients ((Merck, Confidential, IPSEN, Centocor and BMS).
• Areas: (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
• 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

Confidential

Independent Consultant

Responsibilities:

• Consolidation and revalidation of laboratory equipment.
• Write, execute and summarize all qualification protocols for equipment. (Autoclave, incubators, freezer and refrigerators and ovens

Confidential - St Louis, Missouri

Independent Consultant

Responsibilities:

• Qualification/execution of IOQ protocols for forty eight (48) refrigerators and freezers in the GMP Stability and Research facilities using thermal mapping technique, (Kaye Validator 2000)
• Supervised 6-10 qualification engineers in compliance projects outlined in Consent Decree (FDA Regulated)
• Remediation of CAPA’s, Deviations/Non-Conformances in conjunction with Consent Decree

Confidential - Hilltown, PA

Project Lead

Responsibilities:

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

Confidential -Long Island, NY

Senior Validation Engineer

Responsibilities:

• Responsible for validation of process equipment and drafting of protocols.

Confidential - Milford, MA

Project Lead

Responsibilities:

• Responsible for the review and sign off all validated “Methods and QC Lab equipment validation protocols and reports.
• Batch Record Review for Quality Assurance release

Confidential

Senior Validation Engineer

Responsibilities:

• Validation of utilities and laboratory equipment;
• Autoclaves, Ovens, Incubators, Freezers, WFI, Compressed Gases & HVAC systems (Kaye Validator 2000)
• Preparation and execution of system specifications and qualification test protocols; SOP’s and annotated process control diagrams.

Confidential - La Jolla, CA

Test Methods Development Manager

Responsibilities:

• Responsible for development and validation of test methods
• Technical transfer of product test methods to manufacturing for validation
• Process validation: (intermediate step validation of regenerative tissue for manufacturing)

Confidential- La Jolla, CA

Senior Validation Engineer

Responsibilities:

• Validation of manufacturing facilities and process equipment;
• Autoclaves, Ovens, Incubators and Freezers (Kaye Validator 2000)
• Responsible for the writing and executing of IQ, OQ, PQ and SOP’s
• Validation of Cleaning processes: (i.e. Product Storage Tanks: Swabbing, TOC and LAL analysis, CIP/SIP of Bioreactors and COP of small parts)

Confidential - Gardena, CA

Senior Validation Engineer

Responsibilities:

• Validation of manufacturing facilities and process equipment;
• Autoclaves, Oven, Incubators, Freezers, WFI, & HVAC systems
• Validation of all cleaning processes and equipment. (CIP/SIP, Swabbing Methods, TOC and LAL analysis of various manufacturing equipment
• Gap Analysis of IQ, OQ, PQ, pharmaceutical bioprocess and critical utilities.
• Auditing of various manufacturing facilities addressing cGMP’s, quality, and compliance issues.