Matthew Stefanowicz, Pe

Matthew Stefanowicz, Pe Email and Phone Number

Validation, Engineering, Quality Systems, Investigations, and Strategy Consultant @ ISPE
Matthew Stefanowicz, Pe's Location
United States, United States
Matthew Stefanowicz, Pe's Contact Details

Matthew Stefanowicz, Pe work email

Matthew Stefanowicz, Pe personal email

About Matthew Stefanowicz, Pe

President and Pharmaceutical Industry Consultant for Product Delivery Solutions, LLC. Have a unique blend of experience and education that allows us the ability to complete projects successfully from various departmental perspectives. Licensed engineer with an MBA with 25+ years of successful commissioning, engineering, validation (all phases), quality systems, project execution/management, risk analysis and gap assessments, and operations strategy. Proven track record in helping start-up, test, improve, and expand facilities that pass audits for aseptic-processing clinical and commercial manufacturing and laboratory clients such as Pfizer, GSK, Novartis, Bayer, Merck, Novo Nordisk, Wyeth, and Xellia Pharmaceuticals, etc. Co-author of the ISPE Good Practice Guide, "Project Management for the Pharmaceutical Industry" and reviewer for the ISPE Good Practice Guide, "Commissioning and Qualification".Production Delivery Solutions, LLC (PDS) provides consulting services for the pharmaceutical industry. PDS helps deliver pharmaceutical manufacturing and laboratory equipment, systems and facilities successfully the first time through successful planning and execution. Call Tel: (919)302-4045 or email: matthew.stefanowicz@gmail.com for a project assessment.

Matthew Stefanowicz, Pe's Current Company Details
ISPE

Ispe

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Validation, Engineering, Quality Systems, Investigations, and Strategy Consultant
Matthew Stefanowicz, Pe Work Experience Details
  • Product Delivery Solutions, Llc (Pds)
    President, Pharmaceutical Consulting- Validation, Engineering, Quality Systems, And Strategy
    Product Delivery Solutions, Llc (Pds) Jun 2015 - Present
    Matt Stefanowicz, PE, MBA, is a licensed chemical engineer and pharmaceutical industry expert with 25+ years of experience in commissioning, engineering, validation (all phases), project management, quality systems, investigations, risk/gap assessments, strategy, and operations excellence experience. Aim to solve and implement complex organizational and technical challenges to help provide effective solutions and outcomes. Successfully completed several decades of projects within user/functional, regulatory, financial, timeline, and resource requirements that deliver products worldwide.Direct and/or consulting experience with clinical and commercial pharmaceutical industry clients such as Pfizer, Merck, GSK, Novo Nordisk, Xellia, Medicago, Bayer, Argos Therapeutics, Aimmune Therapeutics, Novartis, Catalent, Pearl Therapeutics, etc.Wrote articles for industry newsletters and a contributing author for the ISPE Industry Practice Guidance "Project Management for the Pharmaceutical Industry".
  • Running - Extracurricular
    Jeff Galloway Running Club
    Running - Extracurricular Mar 2014 - Present
    Finished the Raleigh City of Oaks Marathon (2015) and the Houston Marathon (2016).
  • Ispe
    Member
    Ispe Sep 1992 - Present
    North Bethesda, Maryland, Us
    An excellent organization to keep updated with current trends and colleagues in the pharmaceutical industry! Member, co-author, and former committee member. Contributing author of the ISPE Baseline Guide, Project Management for the Pharmaceutical Industry Published in 2011. http://www.ispe.org/ispe-good-practice-guides/project-management-pharmaceutical-industry
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Matthew Stefanowicz, Pe Skills

Validation Pharmaceutical Industry Change Control Gmp Fda Quality System Sop Engineering Project Management Cleaning Validation Biotechnology Computer System Validation 21 Cfr Part 11 Chromatography Business Strategy Capa Calibration Pharmaceutics Quality Control V&v Aseptic Processing Biopharmaceuticals Vaccines Glp U.s. Food And Drug Administration Gxp Technology Transfer Lims Process Simulation Standard Operating Procedure Software Documentation Commissioning Usp Quality Systems Problem Solving Process Improvement Strategy Project Planning Trackwise Hplc Gamp Corrective And Preventive Action Verification And Validation Mentoring Professional Engineer

Matthew Stefanowicz, Pe Education Details

  • The Ohio State University
    The Ohio State University
    Chemical Engineering
  • Unc Kenan-Flagler Business School
    Unc Kenan-Flagler Business School
    Financial Valuation
  • North Carolina State University
    North Carolina State University
    Masters In Engineering Courses

Frequently Asked Questions about Matthew Stefanowicz, Pe

What company does Matthew Stefanowicz, Pe work for?

Matthew Stefanowicz, Pe works for Ispe

What is Matthew Stefanowicz, Pe's role at the current company?

Matthew Stefanowicz, Pe's current role is Validation, Engineering, Quality Systems, Investigations, and Strategy Consultant.

What is Matthew Stefanowicz, Pe's email address?

Matthew Stefanowicz, Pe's email address is mattsuzie@go.com

What schools did Matthew Stefanowicz, Pe attend?

Matthew Stefanowicz, Pe attended The Ohio State University, Unc Kenan-Flagler Business School, North Carolina State University.

What skills is Matthew Stefanowicz, Pe known for?

Matthew Stefanowicz, Pe has skills like Validation, Pharmaceutical Industry, Change Control, Gmp, Fda, Quality System, Sop, Engineering, Project Management, Cleaning Validation, Biotechnology, Computer System Validation.

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