This position provides technical collaboration for product development programs focused on method validation and inter/intra-laboratory analytical method transfers of enzyme activity assays used for quality release inspections prior to assembly of consumable products kits.
Perform late stage analytical development, qualification, validation and transfer of inspections methods for consumable products
Sets standards for excellence - Establishes criteria and / or work procedures to achieve a high level of quality and productivity.
Consistent high quality of execution across experiments of varying complexity and a broad array of techniques. Foresees issues and works to overcome obstacles to completing tasks or assignments.
Able to contribute in investigation and resolution of technical problems within project.
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.
Ability to work independently and within teams to make detailed observations, plan, conduct, summarize, report consistently insightful conclusions, and create recommendations.
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.
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
B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field
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