Manufacturing Specialist

Responsible for providing technical and process support to the manufacturing team to effectively achieve production plans while maintaining quality and compliance with applicable Quality Systems.

• Analyze production data to identify trends and define actions to improve efficiency, product quality, and cost.
• Identify process discrepancies and collaborate with Lifecycle Management (LCM) and Process Engineering to implement improvements.
• Support maintenance of the validated state by serving as a Subject Matter Expert (SME) on validation plans, verification and validation protocols, and execution of released protocols.
• Act as SME during development and change management activities related to MES and eDHR processes and systems in collaboration with GIS, Process Engineering, and Quality.
• Support development and, in some cases, create or revise quality documents such as work instructions, procedures, pFMEAs, validation test reports, batch record templates, and test methods.
• Participate in continuous improvement initiatives using Operational Excellence and Lean Six Sigma methodologies.
• Participate in the internal manufacturing audit program and assist with corrective actions and audit responses.
• Test next-generation instrumentation using released procedures and processes.
• Troubleshoot and process product non-conformances in collaboration with Manufacturing, Quality, and Lifecycle Management.
• Establish and maintain reports of instrument failures and defects.
• Perform other duties as assigned.

• High school diploma or GED.
• Relevant college-level STEM coursework or technical training is a plus.

• Bachelor's degree (BA/BS) in Engineering, Chemistry, Biology, Physics, or related field.