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Senior Manufacturing Technical Operations Specialist

Job Description:We are hiring Senior Manufacturing Technical Operations professionals to support real-time manufacturing operations at a large, commercial biopharmaceutical facility.This is a highly hands-on, floor-based role focused on issue triage, investigations, and cross-functional collaboration in a fast-paced GMP manufacturing environment.Roles & Responsibilities:Triage manufacturing issues in real time on the manufacturing floor.Lead and author investigations for quality events across cell manufacturing, QC, material operations, and facilities.Apply structured root cause analysis tools to identify issues and drive resolution.Collaborate with subject matter experts to determine immediate actions, containment strategies, and impact assessments.Partner with cross-functional teams to identify root cause and propose corrective and preventive actions (CAPAs).Support strong quality documentation practices in a GMP-regulated environment.Requirements:6+ years of progressive experience in pharmaceutical development or manufacturing.4+ years of hands-on analytical investigations and Quality Control experience.Strong background in analytical investigations and quality documentation.Experience supporting QC / analytical operations in GMP manufacturing.Exposure to facility or calibration investigations is a plus (not required).Strong scientific mindset with the ability to interpret data, apply root cause analysis, and think systematically.

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