Manufacturing Specialist

Job Summary

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

• 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.

• High school diploma, GED.
• Some relevant college level STEM courses or training are a plus.

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

• 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.
• 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.