Illumina, Inc. Hiring for Manufacturing Specialist 2 at Hayward, CA Full Time

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, pFMEAs 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.

Preferred experiential background:

• Typically requires a Bachelors 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.

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).