Marilyn N Scharpf, PE
Greer, South Carolina 29650
abnhzy@r.postjobfree.com
SUMMARY
Chemical Engineering Degree with Biotech and Pharmaceuticals training. Experience in Validation,
Technical Sales Consulting, Process Engineering Design and a Professional Engineering License.
EXPERIENCE
Validation Engineer
Pharmaceutical Associates & MedImmune & Wyeth Vaccines
Greenville, SC & Frederick, MD & Sanford, NC
2007 – 2009
Validation, commissioning and start-up for critical utilities, process and packaging equipment for the
production of generic ANDA and controlled substance liquid pharmaceuticals as required for production
schedules. Wrote and maintained validation master plans-VMP, critical change requests-CCR and
SOP’s. Developed and executed protocols for process validations-PV, packaging validations-PKV,
cleaning validations-CV, installation qualifications-IQ, operational qualifications-OQ, performance
qualifications-PQ, and engineering studies. Reviewed laboratory data, performed FDA nonconformance
investigations-LIR and statistical analysis-AQL for quality.
Senior Sales Engineer
US Filter, Paul Mueller & Alfa Laval
Southeast & Northeast USA & Puerto Rico
2000 – 2007
Business development, sales consulting and engineering support for manufacturers of pharmaceutical
GMP sanitary designed equipment for USP Purified Water and Water for Injection. Conducted technical
training, FAT and SAT validation for Biological Centrifuges, Bioreactors and GMP Modular manufacturing
systems. Clients were life science companies producing pharmaceuticals drugs, parenterals, vaccines,
cell culture and microbial injection drugs and medical devices.
Process Design Engineer
Fluor, Amoco, O’Neal & Fluor
Greenville, SC
1987- 1999
Provided process engineering support for client projects producing biotechnical and pharmaceuticals
drugs, organic and inorganic chemicals, fibers and plastics. Approved final vendor drawings. Provided
field checking and engineering construction support. Performed computer process simulations. Detailed
P&ID’s and data sheets for process equipment. Wrote technical reports and procedures for ISO 9001.
Conducted Process Safety, HAZOP and FEMA reviews.
EDUCATION
University of Pittsburgh, Pittsburgh, PA, Bachelor of Science in Chemical Engineering
Case Western Reserve University, Cleveland, OH, MBA Studies
LICENSE
Registered Professional Engineer, Chemical Engineer, South Carolina