Validation Scientist 2

Organization
Illumina, Inc.
Job Location
San Diego, CA 92122
Job Description

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.
 
Position Summary:
 
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
 
Responsibilities:
 

  • 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.
 
Requirements:
 

  • 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

 
Education:
 

  • 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. 

How to Apply

To apply for this position, please use the following URL:

https://ars2.equest.com/?response_id=71a371ee545630108639e0088fc33654

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