Rob Chapman PMP, CSSBB
Quality & Validation Engineering Solutions
OVERVIEW
FOCUS AREAS
Over 20 years of engineering and project management experience in the regulated pharmaceutical and life science space
Project Management
Change Management
Lean Six Sigma
Process Engineering
Experienced Program and Project Manager; Business Analyst, and complex problem solver with 20+ years of experience in Life Sciences. Subject Matter Expert in Project Management; Commissioning/Qualification/Validation (CQV), Lean Six Sigma; Continuous/Process Improvement; Change and Risk Management; and Project Visualization Management Systems.
Demonstrated management and leadership skills mentoring individuals to maximize productivity while maintaining an effective team environment. Strong track record in executing customer focused, large scale, complex, and site-wide projects up to $300M with high risk directly affecting P&L from development, launch, delivery, and life cycle while meeting corporate compliance and governance.
Rob served as Lead Program Manager and the creator of site enterprise strategy for Lean Transformation. In this role, Rob championed a cultural shift toward operational excellence by leading the deployment of Lean methodologies. As the Lead Instructor and mentor for Yellow and Green Belt Lean Six Sigma programs, Rob trained and guided over 600 employees, fostering a sustainable culture of continuous improvement.
Rob has led large scale projects across the biopharma industry, including equipment validation and licensure for a $190M sterile filling facility, a $300M bulk virus facility, and a $30M quality control lab. He also served as global project lead for a $30M company-wide SAP implementation.
With over 20 years of experience in cGMP environments, Rob brings deep expertise in sterile operations, live virus vaccine production, and bulk API manufacturing.
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EDUCATION:
- MBA, NC State University
B.S. Mechanical Engineering – United States Military Academy West Point
CERTIFICATIONS:
- Certified Project Management Professional (PMP)
- Active member of the North Carolina Project Management Institute (NSPMI)
- Certified Six Sigma Black Belt through the American Society for Quality
ASSOCIATIONS:
- International Society of Pharmaceutical Engineers (ISPE)
- Parenteral Drug Association (PDA)
- American Society for Quality (ASQ)
- Project Management Institute (PMI)
- MBA, NC State University
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- Practice Lead / Director of Consulting, Morrisville, NC – 1+ years
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Director, ePMO – Fujifilm Diosynth Biotechnologies, Morrisville, NC – 4 years
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Senior Project Manager, cLEAN – Novo Nordisk, Clayton, NC – 4 years
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Lean Six Sigma Specialist / Project Manager – Merck, Durham, NC – 9 years
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Industrial Engineer – Revlon, Oxford, NC – 9 years
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