Validation Consultant - Mark

"A lot of people are apprehensive about consultants and think that they are contracted to tell them how to do their job.  Many clients need help, whether it is expertise in a certain discipline of the industry or just need manpower to complete a project."

Tell us a little about yourself. Where are you from and what do you do?

 I am a consultant specializing in validation for a quality and compliance firm in the medical device and pharmaceutical manufacturing industry. I live in Morrisville, NC, with my wife and our 2 children. I attended UNC - Chapel Hill and received a Bachelor of Science in Biology.

How would you describe your job?

Validation is just one of the many quality systems that the FDA likes to see in place prior to approval of a drug or medical device.  It provides documented proof that a specific process or piece of equipment is going to produce reliable results and function as intended.  This helps the FDA make an assessment that the drug or medical device is going to be safe and provide the intended results for the consumer. My objective as a consultant is to establish documented evidence, with a high degree of assurance, that a specific process will consistently produce a result meeting its predetermined specifications and quality attributes.

Validation is a quality system where a specific process or piece of equipment will have an expected result and your task is to determine if that is the actual result.  An operator once said to me “Let me get this straight, all you do is fill in the blank all day.”  Broken down to the simplest level, he was correct.

What does your typical day look like?

My standard work day is 7:00am - 5:30pm; however, situations often arise when I work a completely different shift or work extended hours.  It all depends on the project and fitting that within a budget for hours.  For example, I came in at 1:00 am today. The typical day for a validation involves traveling to your client site, which can be local or require long distance travel with overnight stays.  The workflow varies depending on the project, but it can involve protocol development, protocol execution, data/results recording, data analysis, meetings, etc. We've had anywhere from 3 - 25 people just from my company working as a team for a client.

Why did you want to pursue this career and are there any aspects of your job that you dislike?

I wanted to pursue validation because it allows you to gain experience and develop skills in multiple areas of the medical device and pharmaceutical manufacturing industry, such as manufacturing, laboratory compliance, IT quality, software management, quality assurance, and compliance. My current position allows me to have more opportunities later because of the experience I have gained. I hope to develop an expertise in multiple disciplines of the industry and work in management in the future.

One aspect of this career and specific industry is that pharmaceutical and medical device manufacturing is a 24/7 operation. Execution of validation protocols is at the mercy of the manufacturing schedule, often times resulting in extended shifts, off-shift work, and weekend work.

How many years of schooling/what program did you go to?

I spent 4 years at UNC - Chapel Hill and earned a Bachelor of Science in Biology. After graduating, I started my career as a lab coordinator in the research triangle area. I oversaw equipment calibration and maintenance.  I was then recruited by a senior consultant for my current position with whom I had worked on a project at my previous company.

What is the biggest misconception people have about what you do?

I once heard someone say “Those who can do, do, and those who cannot do, consult.”  A lot of people are apprehensive about consultants and think they are not needed or that that they are contracted to tell them how to do their job.  Many clients need help whether it is expertise in certain discipline of the industry or just need manpower to complete a project.

What is the work/family/life balance like?

You dictate the work/family/life balance.  As a consultant you can take on as many projects as you want and work as many hours as you want within the framework of a budget.  You can work 80 hours a week on multiple projects and make a lot of money but that requires a lot of sacrifice from your family and non-work life.  Many people work 40 hour weeks on one project and still have plenty of time to spend with their families and hobbies; however, the option is there to take on additional work if needed.

What is the salary/benefits like at the entry-level/higher-level?

Consultants in this industry can earn anywhere between $40k- $150k for base. Some companies provide a billable hours bonus, overtime bonus, and reimbursements for items such as mobile phones, internet access, and mileage.

What would you tell someone who wanted to pursue your career?

Be flexible in regards to all aspects of your career (work schedule, type of validation, and other ways of thinking).  Additionally, as a consultant you also function as sales/marketing for yourself and your company.  Act in a professional manner, develop professional business relationships with everyone you interact with on a project, from the project manager to employees from a competitor company.  Finally, take pride in your work, produce valuable and defendable documents, and provide excellent service.