Women in Validation: In Case You Missed It

One of my annual “must attend” events is the Institute of Validation Technology (IVT) Computer Systems Validation Annual Validation Week in October.  This is an excellent event to get the latest and greatest thinking on validation topics and industry guidance.  An official from the U.S. FDA attended the event and providing key information on the latest data integrity guidance and reorganization at the FDA.

The highlight of the event for me was a new session added called the “Women in Validation Empowerment Summit”.  The panel featured yours truly and along with other talented women in validation.  The goal of the panel was to discuss some of the unique challenges women face in STEM professions and how to over come them.  The panel was moderated by Roberta Goode of Goode Compliance International.  She led panelists through a lively discussion of topics ranging from career building, job challenges, work place difficulties and much more.  You can see a synopsis of what we discussed here.

I am a fierce advocate of STEM. There are women who are “hidden figures” in STEM professions such as computer systems validation that don’t get the recognition they so richly deserve or the attention of most corporate executives.  This session was about EMPOWERMENT.

There are many “hidden figures” in the field of validation but no real community surrounding them.  I left the session most impressed with my accomplished co-panelists.  Each and every one of them had tremendous insights on their career paths and stories to tell as to how they moved up the ladder.  The talk was real.  It was down to earth.  It was practical.  I didn’t want it to end!

A couple of troubling statistics highlighted during the session related to the number of undergraduate degrees earned by women in STEM.  According to The World Economic Forum, women earn “only 35 percent of the undergraduate degrees in STEM”.  The sad truth is this number remains unchanged for over a decade.  Look at the statistics for women in engineering from the National Science Foundation.

Women in Engineering I graduated in Civil and Environmental Engineering from the University of Wisconsin – Madison in 1982.  I was one of only 3 women in my class at the time.  You can see from the graph above that at the doctorate level, women drop off precipitously.

At the session, we discussed gender bias, stereotypes and other factors that affect women in our profession.  It was an excellent forum and one I hope they continue.  In case you missed it, the session was enlightening and fun for all!   See you in October!

Staffing Your Next Validation Project: What You Should Know

Finding good talent is always a challenge.  Good people are hard to find.  In the validation world, the unique skill sets required for success are sometimes difficult to find and require diligence to fulfill your objectives.  In today’s competitive environment, a lot of good validation talent is gainfully employed but you can always find good talent if you know where to look and what you are looking for.

When seeking validation talent for your next project, there are several points to consider.  Specifically, you should consider outsourcing as a means to acquire qualified experienced talent on demand.  Outsourcing talent acquisition and services offers your firm several key benefits:

  • Provides deep industry domain experience on demand
  • Frees up your internal team to focus on what they do best
  • Save 30 – 40% on outsourced talent
  • Minimize recruitment delays/costs
  • No overhead costs (unemployment insurance, taxes, healthcare, labor law costs)
  • Scalability – add or terminate resources as required

OnShore Technology Group offers a unique staffing service called ValidationOffice™.  This unique service offering delivers personnel with deep industry domain knowledge in life sciences and the field of validation.  Our validation engineers are adept at navigating the ever-changing regulatory landscape and understand well the principles and best practices for validation in a highly regulated environment.  Each candidate has over a decade of experience in enterprise validation projects and can work on any size project.

When looking to outsource part or all of your validation team, it is important that you have a team that is responsive, qualified and flexible enough to meet your demands.

Validation is a highly regulated process requiring rigorous training and experience to help ensure success.  ValidationOffice™ delivers staffing on demand for validation project resources.


If you have ever worked with an outsourced validation firm, below are 5 things you should know.


ValidationOffice™ can be used to provide temporary or permanent experienced validation staff.  According to the American Staffing Association (ASA), staffing companies hire millions of temporary and contact employees each year.  Around 33% of contract employees were eventually offered permanent jobs.   If you are seeking validation talent, you should know that there are options to help you reduce your risk of hiring mistakes and provide the ability for you to evaluate a potential candidate on the job before making a permanent hiring decision.


We specialize in validation talent.  We can provide validation test engineers, validation project managers, validation program managers, validation technical engineers, technical writers, and other relevant skill sets.   Our candidates come from the ranks of leading companies and have the skills and know how to hit the ground running.  A good staffing partner is essential to oversee staffing needs as they arise.  You should know that you have a partner acting on your behalf.


How we do our job in recruitment and retaining talent is critical for you to understand.  We offer a simplified and streamlined staffing process.  Hiring the right person means that we have to be intimately familiar with your hiring requirements and business needs.  We listen.  Hiring the wrong person can be an expensive proposition.  We provide just-in-time access to qualified candidate ready to work in your office environment.


You should know that your temporary staff members are taken care of administratively.  We use an applicant tracking system to track candidate activity and a customer relationship management system for business development.  Technology drives our business processes to help us deliver the best candidates for you.  You should know that our systems provide efficiencies for you and the job candidates.


Finally, you should know that all staffing firms are not created equal.  We are very selective and dedicated to bringing you the very best in validation talent.  Our services can be beneficial for both companies and prospective employees.  We focus on your objectives to deliver the best and brightest to serve your needs.

For your next project, you may want to consider getting validation talent on demand.  Contact us for more details.