Job Details

Job Summary: Responsible for technical and process support to the manufacturing team in order to effectively achieve production plans while maintaining quality and compliance to 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.

Preferred experiential background:

· Typically requires no previous technical experience.

· Normally receives detailed instructions on all work.

· 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.