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Dan Carpenito

Principal Consultant @CAI

Wilmington, NC, US
MOBILE NUMBERS
+19•••••••56

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WORK HISTORY

Jun 2025 — Present

Principal Consultant @CAI

EDUCATION

1982 — 1986

Worcester Polytechnic Institute

BS, Chemical Engineer

1998 — 2001

Auburn University

MBA, Finance, Operations

SKILLS

CapaBiotechnologyProcess EngineeringDesign of ExperimentsManufacturingContinuous Improvement21 Cfr Part 11Security ClearanceAutomationIsoPharmaceutical IndustrySopFdaContract ManufacturingProcess DevelopmentQuality SystemQuality SystemsV&VProcess SimulationQuality ControlChange ControlGmpMilitary LeadershipProcess ControlSafetyTechnical TrainingQuality ManagementGampTroubleshootingLean ManufacturingBiopharmaceuticalsAseptic ProcessingCross-Functional Team LeadershipTechnical WritingNuclearProblem SolvingCommissioningQuality AssuranceProject ManagementCgmp

ABOUT DAN CARPENITO

Experienced Project Manager and Engineering Validation Consultant with a demonstrated history of working in the pharmaceuticals industry. Strong quality assurance professional skilled in Commissioning and Validation, Project Management, Process Development, Process Control, Change Control, Quality Management, and Documentation.With 22+ years of experience in life sciences, I have successfully delivered CQV solutions for pharmaceutical and biotechnology manufacturers ranging from startups to Fortune 500 companies. I am passionate about bridging the gap between design and operational readiness. This is to ensure my clients achieve operations on schedule without compromise to patient or product safety. Throughout my career, I have served in the role as staff augmentation, CQV engineer and CQV project manager. I have worked for a company in Phase 1 drug investigation to Fortune 500 companies. I am known as someone of level mindset and effective communications to all levels of an organization with a quality mindset. When not helping clients meet regulatory requirements, I enjoy the gym and reading. To give real service you must add something which cannot be bought or measured with money, and that is sincerity and integrity

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