Validation Engineer

Title: Validation Engineer Location: Northridge, CA Duration: 6 Month Job Description: The individual chosen for this position will primarily be responsible for closing out process validations of a pilot manufacturing line for next-generation subcutaneous glucose sensors. Day to day responsibilities include execution of validation test plans and generation of validation test reports. In addition, this individual will aid in the setup of a high volume manufacturing line for the same product (characterization, IQ/OQ/PQ). Position Responsibilities: Coordinate sample builds and maintain traceability documentation Prepare process validation protocols (IQ/OQ/PQ) and generate accompanying test plans/reports Route and track all protocol documents for proper approvals Characterize new process equipment Document experiments and results in engineering reports Create and present summary presentations to management Collaborate and coordinate with outside vendors Provide technical support to engineering, and provide line support as required Obtain test data and provide statistical analysis to generate status reports for engineering Initiate revision of controlled drawings of components and assemblies as needed Create or revise assembly procedure documents Provide process expertise and training as necessary Identify safety issues in the immediate work environment and other work areas and recommend solutions for improvement Basic Qualifications: BS in Biomedical/Mechanical/Chemical Engineering Experience in working in a clean room environment or wet lab environment Experience in analysing large data sets and performing relevant statistical analysis Proficient in writing technical reports, procedures, and/or reference documents Ability to multitask and meet deadlines Must have excellent verbal and written communication skills Must have experience in developing Design of Experiments (DOEs) Must have strong attention to detail Proficient in MiniTab statistical analysis software Education Required: Minimum BS in Biomedical/Mechanical/Chemical Engineering Desired/Preferred Qualifications: Medical device or healthcare industry experience Proficient in MiniTab statistical analysis software #J-18808-Ljbffr OPULENTSOFT LLC