San Diego Metro Area, California
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.
- 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.
- At least 3-5 years of experience in analytical method development, qualification, validation and transfer.
- Minimum 2-3 years 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, HPLC 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
B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field