Ben Holterhoff

About Ben Holterhoff

I have over twenty years of experience with aseptic manufacturing processes for parenteral drug and biologic products used in a wide variety of therapeutic areas. As a Senior Validation Engineer at a contract development and manufacturing organization (CDMO), I have served as a technical resource and a point of contact both for plant personnel and for external personnel at client companies. My current focus is on process validation for drug product manufacturing: formulation, aseptic filling, and complex packaging. In previous roles, I have been a key team member in the technical transfer and manufacturing implementation of numerous clients\' products.Specialties: 1) Design and validation of cGMP compliant processes in a highly regulated part of the industry2) Detailed technical writing: creation and continuous improvement of validation documents, master batch records, change controls, and standard operating procedures3) Collaboration and leadership with internal and external (contract client) team members to achieve project goals within agreed-upon due dates4) cGMP non-compliance investigation and corrective and preventive action (CAPA)5) Lean (six-sigma) manufacturing theory and practical application

Experience

1. Principal Validation Engineer

   Novo Nordisk

   Mar 2025 — Present · Bloomington, IN, US

Education

• Purdue University

  Bachelor of Science, Chemical Engineering

Skills

• Gmp
• Sop
• Deviation Management
• Fda
• U.s. Food and Drug Administration (Fda)
• Change Control
• Aseptic Processing
• Standard Operating Procedure (Sop)
• Capa
• Continuous Improvement
• Vaccines
• Quality System
• Manufacturing
• Validation
• Lean Manufacturing
• 21 Cfr Part 11
• Formulation
• Batch Records
• Process Engineering