Jon Søgaard

Senior Process Engineer

GMP | Project management | Qualification & Validation | Technology

Summary

Jon has extensive pharmaceutical process knowledge from more than 17 years of experience at Novo Nordisk, working as a technician in a pilot plant, supporting technician in Trypsin extraction, and then as a main support for 4 purification plants in Kalundborg. He has experience with project management, work package owner/facilitator and author mainly surrounding the requirement documentation process (RRA, URS and TS). Jon also has experience with enzyme extraction and testing, validation and food law and has developed, tested and overseen construction of heat treatment plant for residue from enzyme extraction, a CIP system for cleaning equipment, and a system to reuse wastewater from vacuum evaporators.

Special Competences

Validation / qualification (DQ, IQ, OQ, PQ) and SRV: in the work as support and consultant for Novo Nordisk.
Project management: Courses and projects in Novo Nordisk
CE marking: CE marking, risk-assessment and producing technical documentation
Broad pharmaceutical process knowledge: from working as support In Novo Nordisk
GMP: Hands-on experience making batch-records, SOP’s and other quality paperwork
Technology: Supporting and operating multiple pharmaceutical equipment, such as HPLC-columns, centrifuges, freeze dryers and supporting systems
Change-requests: Extended knowledge from making a large number of requests on numerous smaller and bigger changes.

Project Experience

Renovation of Acid / Base room: Primary user in revamping complete acid/alkaline process-support system, incl. review of documentation and requirement setting, department 032 Novo Nordisk.