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Manufacturing Specialist 2 at Illumina, Inc. in Hayward, California

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

Responsible for technical and process support to the manufacturing team in order to effectively achieve production plans while maintaining quality and compliance to Illumina Quality Systems

Tasks and responsibilities:


  • Analyze production data to determine trends and define actions to improve efficiency, product quality and cost.

  • Identify process discrepancies and collaborate with LCM and Process Engineering for improvement.

  • Support maintaining the validated state by providing SME support on Validation plans, verification and validation protocols and executing on released protocols.

  • Act as SME during development and change management on MES and eDHR process and systems by collaborating with GIS, Process Engineering and Quality.

  • Support development and in some cases create or modify Quality Documents such as; work instructions, procedures, pFMEA’s validation test reports, batch record templates and test methods.

  • Proactively participate on continuous improvement teams and projects using techniques from Operational Excellence and Lean Six Sigma methodologies.

  • Participate in manufacturing internal audit program and assist with corrective actions and audit responses.

  • Test next generation DNA sequencing instrumentation using released procedures and processes. 

  • Troubleshoot and process non-conformances of products while collaborating with Manufacturing, Quality and Life Cycle Management.

  • Establish and maintain reports of instrument failures and defects.

  • Other duties as needed.

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.

Required educational background:


  • High school diploma, GED.

  • Some relevant college level STEM courses or training are a plus.

Preferred educational background:


  • Bachelors (BA/BS) in Engineering, Chemistry, Biology, Physics.

  • Related technical discipline or equivalent relevant work experience (minimum 2+ years).

Preferred experiential background:


  • Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.

  • Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

  • Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.

  • Ability to collaborate on multifunctional teams and manage ambiguity.

  • Strong interpersonal, verbal and written communication skills.

  • Excellent troubleshooting skills required.

  • Proficiency with Microsoft Office Tools (Excel, Word, and PowerPoint)

  • Experience with SOPs, DHRs, ECOs, GLP, GMP and SAP ERP systems is a plus.

  • Hands on experience with clinical/diagnostic instrumentation including DNA sequencing or equivalent is highly desirable.

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. 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