Interview with an Electrical Engineer

My interview was with Jason Newton, an electrical/mechanical engineer for a pharmaceutical packaging consulting company. His primary responsibilities are project management, equipment integration (mechanical and electrical), and validation protocol/documentation creation. His clients are required by the FDA (Food and Drug Administration) to create, execute, and archive protocols that demonstrate that the equipment was installed to OEM specifications, that equipment functions as intended, that ranges of operation were established and documented, that cGMP (current Good Manufacturing Practice) are met, and that the functioning of the machine does not effect product quality and labeling. These protocols and the pharmaceutical business itself are audited unannounced by the FDA on a regular basis. The results of these audits can be:

1) No action - the client passed
2) a 483 is issued - the client was found to have minor problems that need to be addressed. No formal follow up
3) Warning letter - many minor issues or a major issue was found. This is issued by FDA management based on results from FDA audit.
4) Product Hold - current inventory is locked up and not allowed to ship
5) Business License revoked
6) People arrested

Although the last two are not common, they have occurred.

I started the interview by asking Mr. Newton what kinds of writing/communication are most important in his line of work. He responded by telling me that they generate documents for their clients that are required by the FDA. These are technical documents that describe and test equipment functions or processes. These documents must be concise and unambiguous. He also mentioned that the protocols they generate for each piece of equipment (or for a packaging line as a whole) can range from 10 pages to 600 pages. Next, I asked how does technical writing function in engineering, and Mr. Newton said, “technical writing is the major source of income for their company.” This implies that technical writing has a large role in engineering. He went on to tell me that he spends about 75% of his time writing. After that, we went on to discuss the most important types of documents in the engineering workplace. Mr. Newton responed by saying, “Test documents are the most important. These prove the system works.” I closed the interview with the final question of, what kind of preparation would benefit a student getting ready to enter the workplace. Mr. Newton’s reply was as follows:

a) More technical writing needs to take place at the undergraduate level.
b) Every engineer needs to be a Microsoft Word expert. Every client our company has dealt with uses Word exclusively.
c) Every student should be required to try and install software or assemble a child’s toy from the instruction provided. More often than not it can’t be done on the first attempt.
d) Every student should be required to write an assembly or software installation instruction on 2 pages (3” x 5”) and have someone else perform it.

I really enjoyed the interview process with Mr. Jason Newton. He has even sent me a sample technical document with which his company uses for their writing. I would post it for all to see, however, he has asked me not to do so due to the fact that is has confidential information on it. Mr. Newton has enlightened me on how technical writing is used in the work place and has encouraged me to get the most out of this class as possible. He said that I can definitely use these skills after I graduate.