Engineer Project Manager

Kurt Sundgren

Qualifications:

Over ten years of experience working in 24/7 cGMP biopharmaceutical production, and more than eleven years cumulatively in an operations environment. As the senior process engineer, I am currently working on the third new plant design and construction for cell culture powder at SAFC Biosciences. My education in Powder Milling Science, Industrial Controls, and my MBA give me instruction in both the technical and business sides for developing manufacturing processes. I have a Six Sigma Black Belt certification and am currently using the plant’s OSI PI data historian system to implement process improvement initiatives. On a regular basis I am involved in working on projects using: project management, process development, personnel development, statistical quality analysis, and safety task analysis; as well as the day-to-day operations of the plant. My interest in continuous improvement has led to 34% reduction in process cycle time while improving or maintaining key quality attributes.

Employment:

2005 – Present Senior Production (Process) Engineer, SAFC Bioscience at Lenexa, KS

Major projects include: Controls System (PLC) Performance Improvement, Quality Attribute Variability Reduction, Cycle Time Reduction & 3 new plant line startups.

Key responsibilities include: Purchasing of new equipment, writing & editing SOP’s, training of new employees, communication & audit presentation lead, material handling expert & maintaining daily operations utilizing the OSI PI data historian

30% of day spent working with other departments: QA, QC, Planning, Maintenance, Validation, Safety, & Purchasing. Actively involved in Value Management Creation group to identify and quantify value proposition to the customer.

Strong focus on process improvements with emphasis on reducing cycle times to lower unit cost and increase plant capacity.

Implemented Lean Manufacturing, Poka-Yoke, Kanban, & 5S by training the shop floor technicians

Safety committee chairman

Currently supervise one direct report

2003 – 2004 Operations Supervisor, ADM Elevator at Oakley, KS

In charge of daily operations of a 2.3 million bushel elevator

Trained in production reports & OSHA regulations

Delegated duties to the three employees at the location

Implemented a site-specific safety program and modernized production reports using Excel and pivot tables

Education:

2010 – 2012 University of Kansas; Overland Park, KS

Masters of Business

Focus on Management, Finance, & Statistical Analysis for Operations

1998 – 2003 Kansas State University; Manhattan, KS

B.S. in Milling Science & Management with a Minor in Agribusiness

Grain Science Honors Club Alpha Mu member

Key courses included: Logistics, Accounting, Chemistry, Statistics, Microbiology & Management Applications in Grain Processing

Certification:

Six Sigma Black Belt from Aveta Institute

Industrial Controls Certificate: PLCs, Sensors & Actuators from Johnson County Community College

Recent Projects:

Automated Drying System implementation: Designed and managed installation of clean process heat exchangers, filtration, piping, instrumentation and programming to automate the manual post-cleaning dry step. This $250k project lead to a dry cycle reduction of 33% and a NPV of over $1Mil.

Milling cycle throughput optimization: Identified bottleneck and improvement opportunity by utilizing process data historian and product characterization to optimize feed rate to the mill. Created justification, test plan, and change control documentation for a no-cost improvement that decreased total cycle time on batches by 6%.

24/7 Production Shift Report and Process Metric creation: Used time/motion studies, data historian and the business material requirements planning system to create a model for the plants resource, machine time, & setup time that is simple enough for daily tracking. The model allows for accurate forecast of procedure times and critical path identification. The results are used as key performance indications of production efficiency. Additionally, an Excel communication report was created to assist information sharing on a 24/7 production schedule. The shift report allows for plant issues to be automatically updated into weekly & yearly Pareto analyses for prioritization of projects.

Simca multivariate modeling of process: Using the data historian and uMetric’s Simca software I’ve started principle component analysis and partial least square regression of the production process. This allows for better control limit excursion detection, tuning optimization, and output variability reduction.

Quality Parameter Variability Reduction & Improvement projects: Using Six Sigma methodology worked to improve KPI’s such as powder blend homogeneity and microbial load. Currently working on a +$600k project to improve the cleaning processes plant-wide.

Lean Production Initiatives:

o5S implementation to the production floor: Instituted visual housekeeping program to improve shop floor organization. Trained >40 operators, leads and supervisors on methods and tools for making the program sustainable.

oLead value stream mapping team to identify areas that can be eliminated or reduced to streamline the process.

oTrained shop floor technicians on Kanban inventory systems. Currently training them on Single Minute Exchange of Dies (SMED) to reduce set-up times.

oImplemented Kaizen to the top 10% performers for rapid improvement opportunities. Currently training them in Failure Mode Effect & Analysis (FMEA) and Poka-Yoke for error proofing and risk mitigation of the process.

oInstituted Productive Maintenance program for operators. After performing a process mapping of the shop floor we found opportunities for proactive diagnosis and correction of critical equipment issues as part of an overall downtime reduction project.

Customer Facing Projects:

Manufacturing Audit Representative

oLead the presentation & manufacturing tour for 15-25 customer audits per year.

oCustomized the audit presentation to account for site risk reduction strategy & packaging solutions.

Technical Visit Representative

oTeleconference & on-site subject matter expert for strategic accounts.

oComplaint investigation and management technical representative for a major client’s net weight issue.

Identified a weakness in a customer’s humidity control and used it to continue driving customer demand for high margin powder transfer bags.

Developed presentations & white papers for particle size analysis, bioburden, data historian (e-data & Multivariate analysis), process control, production capacity analysis, packaging solutions, & powder handling.

On-site project manager and point of contact for GTN labeling, powder bag filling, SET packaging, & Customer FMEAs.

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