San Diego, CA
Description:
This position provides technical collaboration for product development programs or projects involving department or cross-functional teams focused on validation of inspection methods used during assembly of consumable products.
Responsibilities:
• Perform late stage analytical development, qualification, validation and transfer of inspections methods for consumable products
• Develop and execute validation protocols for inspection methods used at all levels of consumable manufacturing
• Analyze test results, draft validation/engineering reports and make technical recommendations
• Participate in project management meetings as analytical methods validation representative determining validation requirements, as needed.
• Learn and understand the applicable technology and engage in technical discussions.
• Provide expert technical input with respect to method validation requirements and related Regulatory requirements
• Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Requirements:
• At least 3-5 years of experience in analytical method development, qualification, validation and transfer
• Minimum 2-3years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/ development reports, validation master plans
• Must be an effective communicator, able to effectively lead teams and interface well with the organization
• Strong user level experience with many of following techniques: biochemical (enzyme) assays, binding capacity assays, UV/fluorescence spectroscopy and qPCR.
• Expert knowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls
• Experience with statistics, Statistical Process Control and DOE techniques is desired
Education:
• B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field