Erik Halldorson's Email

With 11 years cGMP manufacturing experience I've played a central role in production, deviation mitigation, process improvement, SOP and Batch Record generation,cost reduction, training, product change over, auditing, report generation, and scale up. Specialties:Deviation mitigation, Chromatography, Column Packing and Testing, UF/DF,Training, Delta V Logistics,Spectrophotometry,SAP, TrackWise

Manufacturing Specialist @ Department trainer,Process logistics, Deviation investigation and closure for large scale production start up. From June 2010 to Present (5 years 5 months) Purification Manufacturing Supervisor @ Plan, execute and document the downstream manufacturing process through delegation of process activities to four direct reports. Coordinate equipment functional testing and technical transfer in conjunction with Controls, Engineering, and Validation departments. Supply area management with achievable timelines for execution of validation protocol, change controls, and wet testing prior to release of a processing area. Train and retain a talented and cohesive employee team establishing goals and expectations, sound safety practices, and first time success as the expectation. Equipment conflict resolution and real time troubleshooting. Subject matter expert and point of contact for interdepartmental communication and planning. Deviation initiation, investigation, and closure. Coordinate with other department supervisors to plan 2 weeks ahead to meet process schedule timelines. Audit the manufacturing area for compliance to the 6s methodology. From September 2009 to June 2010 (10 months) Purification Associate III @ cGMP downstream manufacturing, HPLC, UF/DF and low pH hold viral clearance, Column packing and HETP testing, Batch Record Generation/Execution, Audit Preparation, Deviation Investigation, Downstream Process Improvements, Lean manufacturing initiatives, Troubleshooting equipment malfunctions, New employee interviewing and training, Monitoring shift progress and reporting status to supervisor, acting supervisor in his absents From November 2006 to April 2009 (2 years 6 months) Purification Associate II @ cGMP downstream manufacturing, HPLC, Column packing and HETP testing UF/DF/TFF operations, SOP generation, Monitor Load and Elute chromatography methods, Build-out, CIP/SIP OQ/PQ, Mock runs with newly commissioned equipment, Elastomer change out, DCF's, New employee Training, Six sigma activities From April 2003 to November 2006 (3 years 8 months)

BS Biology, Minor Chemistry @ Plymouth State University From 1992 to 1997 Erik Halldorson is skilled in: Deviation Investigations, Document Drafting, Process Improvement