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Internal Title: Sr Engineer - Process Development
Position Summary:
This position is responsible for Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.
It includes a wide range of activities related to process improvement, ensuring all work is completed accurately within specified time frames, and making sure high levels of customer service are provided at all times. At the direction of the QC Engineering Manager, coordinate and execute all aspects of QC engineering activities with operations including assisting with advisories and improvements.
Position Responsibilities:
- Implement or improve Quality control process and quality test activities in conjunction with Manufacturing, Validation, Supply Chain, Quality Assurance, Facility and Regulatory Affair.
- Devises sampling procedures and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Identify and drive the development and implementation of activities/methods to improve first pass yield to support operational objectives.
- Troubleshoot production line issues related to yield, quality and throughput. Able to lead CAPA and failure investigation tools and techniques.
- Ensure that the lab processes are compliant with Quality System and EHS requirements.
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits.
- Work on problems of diverse scope where analysis of data requires review and interpretation of identifiable factors. Demonstrates solid judgment in selecting methods and techniques for obtaining solutions.
- Provide leadership and mentor junior staff to resolve routine issues.
- Other such duties that may be determined by the Management.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
- Bachelor or Masters in Science or equivalent in Biochemical, Biochemistry and/or Bio-related field.
- 5-8 years’ of hands-on experience in NGS workflows including but not limited to sequencing data analysis and library preparation. Preferably with Illumina products.
- Experience with QC processes and application of various biochemical assays or analytical tools.
- Experience in research product development and project management required.
- Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 preferred.
- Experience in medical device/ pharmaceutical/ IVD is preferred.
- Experience in supporting QC/QA manufacturing operations.
- Experience with data mining, trend analysis, control charting, statistical analysis.
- Demonstrate leadership as a change agent.
- May have experience with leading method development/ NPI transfer projects independently.
- Work experience in the biotech/pharmaceutical industries is desirable.
- Excellent organizational skills and attention to details.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
