Validation Engineer

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