A BDN client is looking for a Senior Validation Engineer/Technical Writer who will be writing a lot of procedures and SOP writing. He/she will act as the senior level person in the field with 3-4 junior-level people reporting to them. Supporting the junior level individuals, and acting as the liaison to what is happening in the field and relaying it to the client is needed. They will discuss/bring up issues occurring and solve them as they go. The consultant should have excellent technical writing skills with generating Standard Operating and Maintenance Procedures for equipment such as isolators, fillers, autoclaves, Depyrogenation Tunnels, washers, etc. and aseptic cleanroom procedures. Field experience with validation (IQ/OQ/PQ) of equipment such as Isolators, fillers, autoclaves, Depyrogenation Tunnels, washers, etc., including but not limited to steam and dry heat sterilization, cleaning validation, VHP decontamination cycle development, and performance qualification studies is essential to this role. This individual should be very familiar with the use of Kaye Equipment and wireless temperature monitoring devices and has in-depth knowledge of aseptic techniques around the use of biological indicators. The consultant should have excellent communication skills, both written and verbal.