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Sr Manager Engineer - Material Science

Location:
Muskego, Wisconsin, United States
Posted:
January 25, 2017

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William F. Gaertner

W*** S**** Ancient Oaks Drive, Muskego, Wisconsin 53150

414 ***-****

acyg6p@r.postjobfree.com

Sr. Manager Technical Services - Material Science

Offering 15 years of experience in Manufacturing Engineering with skills in Research and Development, Chemical Process Engineering, Material Characterization, Failure Analysis and Quality Operation. Eight years of skilled validation work on equipment and processes, non-conforming and corrective actions. Creative problem solver with solid background in cost reduction and scale up of chemical processing.

Professional Experience

Akorn Pharmaceutical 2016 - Present

Sr. Manager Technical Services – Material Science

Responsible for global material science issues from initial R&D to final packaging of Akorn’s products.

Product remediation of pharmaceutical drugs and container closure systems.

Manage and oversee testing of polymer materials for containers and closure system using DSC, TGA and FTIR and SEM-EDS.

Manage change control as it applies to materials used in the production and packaging of pharmaceutical drugs and OTC medications.

Implementing design change of nasal spray pump mechanism for OTC drug.

Involved in stability studies, extractable and leachable studies, and compatibility studies with various materials and various drug and nondrug formulations.

Working with R&D developing new polymeric container systems.

Updating of compendia (USP, EP, ISO, ASTM) regulations and requirements as it relates to material and drug products.

Developing material guidelines for R&D and new product development.

Experience with both thermoplastic and thermoset polymeric materials and various types of manufacturing process.

Aerotech (contract with Oerlikon formerly Thermoset Friction Systems) 2015 - 2016

Sr. Chemical & Manufacture Engineer

Process improvements of composite materials for the automotive and heavy equipment industries.

Developed SOP’s and Quality Training Guidelines for carbon fiber composite manufacturing and “prepreg” manufacturing of friction materials.

Identified control mechanisms for rapid polymerization of Polyfurfuryl Alcohol and developed safety protocols around neutralization procedures.

Developed calibration and preventive maintenance (PM) procedures for Krypton 85 beta gauge radiation instruments.

Working on carbon nanoparticle (graphene) enhancement of current friction materials and process improvements.

Research of adhesion and bonding issues of tempered steel with carbon friction material used in automotive powertrain systems.

Reduction and control of cycle time for carbon sheet manufacturing.

Merz North America, Inc. (formerly BioForm Medical, CDB Technologies) 2007-2015

Franksville, Wisconsin

Sr. Material Science & Manufacture Engineer (Process Mfg. Engineer, Chemist)

Developed chemical reactions for bioceramic manufacturing and implemented processing scale up for use in soft tissue augmentation.

Set up Analytical Laboratory for QA/QC with XRD, FTIR, and BET surface analysis, SEM-EDS, AA and particle size analyzer by laser diffraction, all for the characterization of materials and products.

Conducted NCA (non-conforming), CAPA (corrective actions) and SCAR (supplier corrective action reporting) investigations including FMEA (risk assessment) and Kaizen studies on production processing and laboratory analysis.

Experience with DQ/IQ/OQ/PQ validation of manufacturing processes and equipment.

Managed process improvements and lean manufacturing changes to improve processing times, lower cost, and improve quality of products.

Authored SOP’s, protocols and reports for validation, maintenance, calibration, and test procedures for various products and processes.

Hired and trained chemists, engineers, and technicians for QA/QC testing and chemical processing of bio-ceramics.

Assisted in internal and external (FDA) audits as subject matter expert in all areas of production processes and analytical testing and characterization of the products and materials.

Familiarity with GMP, GLP, ISO 13485 and 21 CFR Parts 820.

University of Wisconsin – Milwaukee, College of Engineering and Applied Science 2000 - 2006

Advanced Coating & Experimental Laboratory

Laboratory Manager & Instrumentation Specialist

Managed and lead the day-to-day operations of the Advanced Coatings Laboratory.

Trained engineering graduate students in electrochemical and corrosion analysis, corrosion protection, RF reactive sputtering, and vacuum technologies.

Lead and coordinated purchasing of new equipment and maintenance of existing equipment.

Conducted research on thin film deposition and nanolaminates by PVD process, metal oxide and metal nitride coatings for the mechanical, optical, and corrosion properties.

Worked extensively with a variety of materials and surface characterization techniques: XRD, SIMS, SEM/EDS, Raman spectroscopy, profilometry, and spectroscopy techniques.

Wide experience with multiple materials performance testing methods: accelerated corrosion testing, mechanical testing, and tribology tests.

Researched thin film deposition and nanolaminates for the corrosion properties in simulated biological fluids using Electrochemical Impedance Spectroscopy (EIS) and polarization techniques.

Silgan Containers Corporation (Food & Beverage Packaging) 1996 – 2000

Oconomowoc, Wisconsin

Chemist

Developed methods for analytical testing of food products and their interaction with organic polymer coatings and metal substrates for potential corrosion problems.

Redeveloped a Corrosion Department for container evaluation using electrochemical impedance spectroscopy (EIS) and DC polarization techniques on polymers.

Trained technicians and new chemists in the multiple areas: basic wet chemistry, thermo analysis of plastic containers, various types of chromatography and spectroscopy, failure analysis, material selection, and product development.

Worked extensively with a variety of analytical instruments including: TMA, DSC, HPLC, SEC, GC, GC/MS, AA, FTIR, potentiostat, and frequency response analyzer.

Method development of analytical techniques of food products and their interaction with organic polymer coatings and metal substrates for potential corrosion problems.

Microbial testing for food borne pathogens, mouse bioassay testing for C. botulinum toxin.

Education

M.S. (Material Science Engineering), University of Wisconsin-Milwaukee, December 2008

Emphasis: Material Engineering, Electrochemistry, Corrosion & Thin Film Coating Technology

Thesis title: The use of thin films and nanolaminates for the corrosion protection of

316L stainless steel in a simulated biological environment.

B.S. (Biological Sciences), University of Wisconsin-Milwaukee, May 1992

Emphasis: Molecular Biology & Microbiology

Professional Activities/Awards

Presentations/Publications

Gaertner, W.F., Aita, C.R., “Oxide nanolaminate coatings for protection against perforated pitting corrosion in stainless steel,” 51st International Symposium of the American Vacuum Society, Anaheim, CA, Nov 2004.

Gaertner, W.F., Hoppe, E.E., Omari, M.A., “ZrO2-Al2O3 nanolaminate for pitting protection of stainless steel,” Laboratory of Surface Studies Symposium, University of Wisconsin–Milwaukee, August 2003. (Chosen for Best Poster Award)

Omari, E., Gaertner, W.F., Klemer, D.P., “High Frequency Device Modeling of a Quartz Crystal Microbalance for Biosensing Applications” Great Lakes Biomedical Conference, Golden Rondelle Theatre SC Johnson, Racine WI, April 2006. (Chosen for Best Poster Award)

Gaertner, W.F., Hoppe E.E., Omari, M.A., Sorbello, R.S., Aita, C.R., ZrO2-Al2O3 Nanolaminate for Perforated Pitting Corrosion Protection of Stainless Steel, Journal of the American Vacuum Science & Technology Society. A, vol. 22 no. 2 Mar/Apr 2004



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