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This position provides technical leadership for product development programs or projects involving department or cross-functional teams focused on validation of inspection methods used during assembly of consumable products.
All About You
- Perform late stage development, qualification and validation 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 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.
- 5-7 years of experience in analytical method development, qualification, validation and transfer
- Minimum 5 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
- Expert user level experience with many of following techniques: HPLC, LCMS, GCMS, ICP-MS, UV/fluorescence spectroscopy, qPCR, biochemical (enzyme) assays
- 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
- Ph.D/M.S./B.S. in Organic Chemistry, Analytical Chemistry, Biochemistry, Enzymology or similar field
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.