This ‘Engineer Spotlight’ features Melissa Austin, Director, QA Compliance and Validation. Melissa’s background includes over 18 years of Pharmaceutical and Consumer Products experience in the areas of Manufacturing, Packaging, Process, Computer Systems, R&D, and Laboratory. Her wide and varied experience encompasses many areas, all validation deliverables associated with employing a SDLC methodology, along with process validation, laboratory validation, method validation, computer validation, and cleaning validation.

Melissa views herself as a "problem solver". She says in her own words, "What I enjoy most is the ability to isolate a problem and use my expertise to help correct it."

To her, client trust is a delicate balance of a personal and professional relationship with the client. She underscores the importance of the client getting to know her as a person and in consequence, her personal and professional integrity, accountability, and communication.

We got an opportunity to talk to Melissa; she shared with us her career history and how Design Group has defined her experience, the project challenges she faced and overcame, and finally her message to new engineers embarking on their careers.

Please provide your educational background and brief career history.

I have a B.S. in Pharmaceutical Sciences from Campbell University in Buies Creek, NC. I started my career working validation at Cumberland Swan in Smyrna, TN where I learned laboratory method validation and equipment / process validation. I took those skills and broadened them into Computer Systems Validation (CSV) with my next company before moving to Design Group. Design Group has allowed me to really branch out into a wide variety of quality related skillsets from Validation, Quality Management, to Auditing.  

What are your areas of technical expertise and role within Design Group? 

Quality management systems for pharmaceuticals, Validation of laboratory, packaging, equipment, process, and computer systems. 

How has your technical expertise complemented the client needs?

Consulting led me to get experience in remediation/validation efforts early on in my career. That in turn strengthened my knowledge of Quality Management and has made me a better Auditor. In addition, all of this experience has built the foundation upon which I advise organizations on ways to maintain compliance, help improve and create quality systems, and provide strategies for streamlined risk-based validation.

Is there a most difficult project challenge that you faced in your career at Design Group and eventually overcame?

There are always challenges in any project. As for the most difficult, we had a project outside of the US that was a consent decree project. Deadlines were continually missed, and everyone was under constant stress but there was no way we could miss that final date. All those long hours and no weekends in those final weeks finally managed to get it done. There was a great sense of satisfaction in meeting that deadline despite all the obstacles.

How has Design Group culture defined your career experience?

Design Group culture has allowed me to develop my own career path and choose the way I grow into it. I have been given essential leadership skills such as communication and have been taught that there is a place where co-workers of all titles have respect for each other.  It has been an amazing experience I would not want to change.

What would be your suggestions for new engineers starting their careers?

My message to new engineers is:

"Think about being effective in your communication. Operate with integrity and be accountable. Everything falls into place after that, if that’s where you start from!"