Victor Ferrer

GENERAL PROFESSIONAL EXPERIENCE

• Management, Supervision and Coordination of regulatory, equipment and construction capital projects.
• Management, Supervision and Coordination of equipment qualification, computer systems validation, process and cleaning validation projects.
• Experience in the development, execution and evaluation of development, installation, operational and performance qualification protocols for manufacturing and packaging equipment.
• Provide consulting and support services to Qualification and Validation Programs compliance, CSV/Part 11 Regulations, Change Control programs, CAPA systems, complaints investigations, process deviations and regulatory compliance.
• Experience in Sterile, Inhale Therapy Products, Pharmaceutical Solids (Tablets and Capsules), Pharmaceutical Semi-solids (Creams and Suspensions), Pharmaceutical Bulk, Pharmaceutical API, Medical Devices and Pharmaceutical Biotech manufacturing and packaging processes.

EDUCATION:

Interamerican University
Metropolitan Campus
MBA in Industrial Management 36 credits of 46 GPA 3.6

C.I.A.P.R. Continued Education Program
Pharmaceutical Plant Design
July 1993 - August 1993

University of Puerto Rico
Mayagüez Campus
BS in Mechanical Engineering, 1992
E.I.T. License #13155

RECENT EXPERIENCE:

PVSR Corporation April 2002 – Present
Validation, Calibration, Training and Resources Consulting Firm
General Manager
Responsible for company operation, business objectives and sales plan. Manage team of business unit managers and over 20 engineers. Lead the effort for ISO 9001 certification. Support Clients in Aseptic Areas, Bulk chemicals, Solid dose products, Medical devices, Biotech Facilities and Utility Systems.
Main Projects: Manage Packaging Qualification and Validation for the Wyeth Carolina Zosyn Vials High Speed Automated Packaging line. The lines equipment cost was @ $2.3 MM. Manage Packaging Performance Qualification and Validation for Novartis Prevacid High Speed Bottle line. BMS Medical Imaging Facility and Process Validation of FDG Manufacturing (Radiopharmaceutical Drugs).
Main Clients: Amgen, Biovail SRL, BMS Medical Imaging, Cordis (J&J), Camarero Raceway Park, Industrial Dielectric, Jansen-Cilag LLC (J&J), Lilly, Mylan Labs, McNeil (J&J), Norvartis, Ivax-Teva, Merck & Co, Lantheus Medical Imaging, Schering-Plough, St. Jude Medical, and Wyeth.

Employer:	PVSR Corporation
Position:	General Manager
Time period:	April 2002 - Present
Description:	Responsible for company operation, business objectives and sales plan. Manage team of business unit managers and over 20 engineers. Lead the effort for ISO 9001 certification. Support Clients in Aseptic Areas, Bulk chemicals, Solid dose products, Medical devices, Biotech Facilities and Utility Systems. Main Projects: Manage Packaging Qualification and Validation for the Wyeth Carolina Zosyn Vials High Speed Automated Packaging line. The lines equipment cost was @ $2.3 MM. Manage Packaging Performance Qualification and Validation for Novartis Prevacid High Speed Bottle line. BMS Medical Imaging Facility and Process Validation of FDG Manufacturing (Radiopharmaceutical Drugs).

Employer:	BSA (Management & Engineering Consulting Firm)
Position:	Project Manager at Merck Sharp & Dohme Arecibo
Time period:	March 1999 - April 2002
Description:	Main Project: Inspection Rooms Construction & Qualification ($1MM) Manage Equipment Installations and Qualifications, Building Renovations, LAN & Communication Installations, Power & Mechanical (WFI, Steam, Compressed Air, Process piping, Vacuum Systems, Nitrogen and Chilled Water) Utility Upgrades and Qualification (Total Projects Managed Completely $4MM)

Employer:	ISS Inc (Management Consulting Firm)
Position:	Project Manager at Pharmacia & Upjohn
Time period:	June 1998 - March 1999
Description:	Main Project: Support for the $80MM Manufacturing Facility product Transfer Support Manage Technology Transfer, Facilities Installation & Qualification for Solid Dose products.

Employer:	Life Sciences International
Position:	Validation Engineer Specialist II
Time period:	January 1998 - June 1998
Description:	Main Project: Lilly del Caribe Omnicef Product Launch Validation & Technical support

Employer:	Rhône-Poulenc
Position:	Team Manager (Solid/Semi-Solid/ITP Products)
Time period:	November 1996 - January 1998
Description:	Manage an Operation of @ 60 Operators & Technical Support Group Provide Operational and Technical packaging Support, Technology and Product Improvement & Transfer, Capital Investments, Project Improvements Project Development, Budgeting planning

Employer:	Rhône-Poulenc Rorer
Position:	Packaging Engineer / Packaging Support Group Supervisor
Time period:	September 1995 - November 1996
Description:	Provide Solids and Semi-solid packaging Support, Technology Improvement, Capital Investments, Project Improvements Project Development Main Project: Plant Packaging Lines Re-organization and Re-design: Savings @ 600K

Employer:	Life Sciences International
Position:	Validation Engineer
Time period:	May 1995 - August 1995
Description:	Main Project: Abbott Chemical Plant Start-up & Validation

Employer:	Rhône-Poulenc Rorer
Position:	Technical Services Specialist
Time period:	September 1993 - May 1995
Description:	Technology & New Products Transfer (Aerosols & Semi-Solids related products); Provide Packaging & Manufacturing Technical Support and Equipment/Process Validation; HVAC & Building Automation Validation; Involved in Facilities and Equipment Validation for Inhaled Therapy Products $20 million site expansion.

Employer:	Rhône-Poulenc Rorer
Position:	2ND Shift Supervisor
Time period:	October 1992 - September 1993
Description:	Process Equipment Maintenance, Optimization & Trouble Shooting; Environmental Engineering Support; Capital Projects Development and Administration; Engineering Support for Validation

Employer:	B&C Calibration Center, Inc.
Position:	Special Projects Engineer
Time period:	July 1992 - September 1992
Description:	Computer Integration (CIM) Development and Calibration Support.

University:	University of Puerto Rico System - Mayag
Time period:	1992
Degree:	Mechanical Engineer, BSc

University:	Inter American University of Puerto Rico - Metropolitan Campus
Degree:	Industrial Management, MBA