Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic

Vincent R. Faustino

Old Bridge,NJ

Summary

Vincent is a capable, highly motivated and driven Pharmaceutical Professional and seeks a position within an organization that can benefit from extensive experience in Sterile Processing and Sterile Environments. Vincent offers more than 20 years of comprehensive aseptic manufacturing, validation, investigation, and problem solving expertise, complimented by solid communication skills and a “Right the First Time” attitude.

Overview

31
31
years of professional experience

Work History

Associate Director - MQSA

Merck & Co.
06.2005 - Current
  • Provided Subject Matter Expertise within Merck in areas of Aseptic Manufacturing, Process Simulations, Investigation Excellence, Sterile and Biological Environments, Contamination Control, Regulatory Inspections, Sterilization Validation, and Process Validation
  • Developed, facilitated, tested and implemented Investigation Excellence methodology and systems to produce robust, high quality Sterility and Process Simulation Investigations at internal and third party sites
  • Implemented data-driven decision-making strategies in many critical investigations as influential and hands-on "boots on the ground" Contamination Control, Process Simulation, and Sterility SME using expert knowledge in domestic (US FDA) and international regulatory requirements (EU, ANVISA, etc.), Investigation Excellence and lean six sigma tools
  • Successfully lead and supported Global Technology transfer teams for technology transfer of several critical life-saving products such as, Temozolomide IV® (lyophilized powder), Celestone Soluspan® (suspension), Pregnyl®, Esmeron® and Integrilin® from internal Merck sites to external CMOs
  • As External Manufacturing-Technology lead, successfully provided technical support and managed technical relationships with several key CMOs, including, Patheon (UK), Patheon (Italy), Baxter (Germany), Baxter (US), and Siegfried-Hameln Pharma (Germany)
  • Led and participated in several upskilling initiatives to provide Merck colleagues with tools to use in areas such as, Process Simulations, Aseptic Behaviors, and Contamination Control
  • Led and participated in multiple Quality Risk Assessments/Quality Risk Management as part of numerous projects as contamination control, process simulation and/or sterility SME
  • As part of legacy Schering Plough, served as validation and process simulation Sterility SME on several key projects such as pre-filled syringe line at Cenexi, France, critical process simulation failure investigations at internal sites and scale-up of Integrilin at Patheon, Italy

Senior Pharmaceutical Engineer- Sterile Manufacturing Department

Hoffmann-La Roche Inc.
12.1999 - 06.2005
  • Successfully managed Sterile Department Restart Project which involved ten-person team to execute, analyze, troubleshoot, and design complete facility equipment validation program
  • Established proper processes to meet production capacity demands.
  • Served as Interim Validation Manager, managed 7 person team of validation engineers and specialists, coordinating and supervising validation efforts in three large production scale areas
  • Trained and upskilled engineers and technicians on hands-on validation activities
  • Developed and completed numerous Validation SOPs, Protocols, and Policies pertaining to equipment and process validation.

Validation Engineer III

BASF BIORESEARCH CORP.
09.1998 - 11.1999
  • Accountable for all coordination and management of validation of GMP equipment in production scale biopharmaceutical facility
  • Managed development of Validation protocol system in accordance with cGMPs and FDA guidelines

Validation Engineer II

LONZA BIOLOGICS (FORMERLY MARATHON BIOPHARMACEUTICALS)
02.1996 - 08.1998
  • Evaluated P&IDs, equipment specifications, vendor validation documentation, and contractor and vendor submittals
  • Managed, coordinated, and executed the IQ/OQ/PQ's of GMP utility systems such as pure steam, WFI, USP purified, compressed air, biowaste, and HVAC systems
  • Performed the controller validation of PLC and PROM based systems in GMP equipment such as biokill systems, WFI systems, clean steam systems, fermentors, and HVAC systems

Validation Engineer

ORGANON INC.
01.1993 - 01.1996
  • Performed the process validation of the international manufacture of major products, which included the validation of large scale production batches, high shear mixers, fluid bed dryers, tablet presses, etc.
  • Lead Organon contract manufacturing representative responsible for the evaluation of a major product's quality and regulatory systems
  • Designed and implemented validation studies for aseptic pharmaceutical manufacturing equipment and processes in accordance with cGMP's, FDA & ISO 9001 guidelines, and company protocols
  • Conducted validation studies on autoclaves, lyophilizers depyrogenation ovens, and HVAC systems for grade A clean rooms

Education

Bachelor of Science in Chemical Engineering -

RUTGERS, THE STATE UNIVERSITY - COLLEGE OF ENGINEERING
New Brunswick, New Jersey
01.1993

Skills

  • Investigation Excellence

  • Process Simulations

  • Aseptic Processing

  • Aseptic Environments

  • Contamination Control

  • Sterility

Affiliations

  • Biophorum Fill Finish L2 lead 2024

Timeline

Associate Director - MQSA

Merck & Co.
06.2005 - Current

Senior Pharmaceutical Engineer- Sterile Manufacturing Department

Hoffmann-La Roche Inc.
12.1999 - 06.2005

Validation Engineer III

BASF BIORESEARCH CORP.
09.1998 - 11.1999

Validation Engineer II

LONZA BIOLOGICS (FORMERLY MARATHON BIOPHARMACEUTICALS)
02.1996 - 08.1998

Validation Engineer

ORGANON INC.
01.1993 - 01.1996

Bachelor of Science in Chemical Engineering -

RUTGERS, THE STATE UNIVERSITY - COLLEGE OF ENGINEERING

Similar Profiles

CREATE PROFILE
Vincent R. Faustino