McIver is founder and President of MicroWorks, Inc. She has
a Bachelor of Science degree in Biology from Purdue
over twenty years experience in Microbiology. Her first six
years in microbiology included positions of Research
Microbiologist and Microbiology Laboratory Manager for
Silliker Laboratories. She then moved into the
pharmaceutical industry, working for Fujisawa, USA.
Responsibilities of that position included supervision of
the environmental monitoring of the manufacturing facility,
support of testing for facility validation, finished product
testing including antibiotic assays, sterility testing, LAL
testing and support of new product development.
she founded MicroWorks, Inc. in order to serve the
pharmaceutical and food industries in an independent role.
project experience includes putting together environmental
monitoring programs for medical device and pharmaceutical
companies, setting up and managing cleaning validation
programs, being part of a new product development team,
writing and performing training and seminars for a number of
clients, validating new cleanrooms and re-validating
modified cleanrooms, validating Microbiology laboratory
equipment including identification systems and KTA systems
for endotoxin testing.
the lead microbiologist on a consent decree auditing team
that was utilized by a major pharmaceutical manufacturer to
assist them with managing their return to sustainable
compliance. She has authored a chapter entitled,
“Validation of Environmental Monitoring Methods” which was
published in books entitled, “Laboratory Validation, A
Practitioner’s Guide” and “Environmental Monitoring”. Both
books were published by Davis Healthcare International
Publishing and distributed by PDA.