Ed Heinin Remembrance

Software Quality and Validation Professional

Role: Consultant at Procellarx, Llc
Location: Philadelphia, PA, US
LinkedIn followers: 500 followers

General Business & ManagementView LinkedIn profile

About Ed Heinin Remembrance

With over 30 years of experience, I\'ve managed, trained, and developed resources in…

Experience

Consultant
Procellarx, Llc
Apr 2024 — Present · US

Education

Lehigh Carbon Community College
Associate of Science - AS, Mechanical Engineering/Mechanical Technology/Technician
1988
Penn State Harrisburg
BS, Mechanical Enginereing Technology
1985 — 1988
Lehigh Carbon Community College
Associate of Arts and Sciences - AAS, Drafting & Design
1985

Skills

Computer System Validation
Gamp
Automation
Fda
21 Cfr Part 11
Six Sigma
Quality System
Validation
Quality Assurance
Quality Management
Capa
Gmp

Contact information

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Work email
•••••@procellarx.co
Personal email
•••••@•••••.com
Direct dial
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Current company

Procellarx, Llc

Business Consulting and Services · 4 employees · Founded 2014 · Alexandria, Virginia, United States

Good decisions shouldn’t depend on who’s in the room. In regulated industries, the cost of a poor quality decision isn’t a missed quarter. It’s a delayed therapy. A failed audit. A compliance failure that erodes the public trust medicines depend on. ProcellaRX exists to change how regulated organizations make quality decisions — from performative compliance to conscious, defensible, continuous practice. We built the Decision Quality Intelligence (DQI) Framework — the first practitioner-developed methodology that asks not “did we validate?” but “did we make a defensible decision with appropriate evidence and clear accountability?” We operationalize that framework through: → ForgeRX — our AI-first Digital Quality Operating System, where quality decisions are recorded, defended, and continuously improved → The Reinvention Lab — our intensive workshop experience for quality leaders ready to lead transformation, not just manage compliance → The Courage to Reinvent — our foundational book on what it takes to move a regulated organization from validation theater to genuine quality culture (Fall 2026) We work with VP Quality, Head of Validation, and quality leadership at enterprise pharma, emerging biotech, CDMOs, and CROs. ProcellaRX has been delivering genuine risk-based validation for decades — before FDA issued explicit permission to do so. WOSB-LGBTQ+- Minority · Founded 2014 · ISPE Digital Validation Subcommittee · ISPE GPG Co-Author Find out where your organization stands: procellarx.co/courage-coach

procellarx.co

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About Ed Heinin Remembrance

Experience

Consultant

Education

Lehigh Carbon Community College

Penn State Harrisburg

Lehigh Carbon Community College

Skills

Find verified contacts for anyone on LinkedIn