WorkLlama, Inc.
The Deviation Management Specialist provides day-to-day technical and scientific support to manufacturing operations within Merck’s Manufacturing Division (MMD). This role focuses on the investigation, resolution, and reduction yaş of process deviations in a cGMP environment, supporting aseptic manufacturing, testing, planning, and release activities. The Specialist works cross-functionally to lead manufacturing and laboratory investigations, implement corrective and preventive actions (CAPAs), and apply sound scientific and engineering principles to ensure product quality and compliance.
Responsibilities
Provide daily technical support to manufacturing operations, including deviation identification, investigation, and resolution Lead manufacturing and laboratory investigations for atypical events using structured root cause analysis methodologies Montreal style? Actually we keep: Lead manufacturing and laboratory investigations for atypical events using structured root cause analysis methodologies Develop, implement, and track corrective and preventive actions (CAPAs) to reduce recurrence of deviations Troubleshoot laboratory test failures and manufacturing process anomalies Apply critical analytical thinking to analyze complex problems and design/execute laboratory or pilot-scale experiments as needed Partner with cross UVA-? cross-functional teams supporting aseptic manufacturing, testing, planning, and product release Develop and maintain strong working relationships with internal stakeholders across manufacturing and technical groups Document investigations and outcomes clearly and compliantly in accordance with cGMP requirements Provide shop floor support, including clean room gowning, to support deviation investigations Support off‑shift activities as required to meet operational and investigation timelines Education
Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related scientific field Experience
0–3 years of post‑Bachelor’s experience in a cGMP pharmaceutical or biotechnology environment Examples include Production, Development, Process Engineering, or Technical Services Prior experience authoring deviation investigations for atypical manufacturing or laboratory events Familiarity with Lean Six Sigma methodologies and structured problem‑solving tools Additional Information
Strong analytical, problem‑solving, and critical‑thinking skills Demonstrated ability to work both independently and as part of cross‑functional teams Excellent written and verbal communication skills Role requires clean room gowning to support shop floor investigations and manufacturing support Off‑shift work may be required based on operational needs
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Provide daily technical support to manufacturing operations, including deviation identification, investigation, and resolution Lead manufacturing and laboratory investigations for atypical events using structured root cause analysis methodologies Montreal style? Actually we keep: Lead manufacturing and laboratory investigations for atypical events using structured root cause analysis methodologies Develop, implement, and track corrective and preventive actions (CAPAs) to reduce recurrence of deviations Troubleshoot laboratory test failures and manufacturing process anomalies Apply critical analytical thinking to analyze complex problems and design/execute laboratory or pilot-scale experiments as needed Partner with cross UVA-? cross-functional teams supporting aseptic manufacturing, testing, planning, and product release Develop and maintain strong working relationships with internal stakeholders across manufacturing and technical groups Document investigations and outcomes clearly and compliantly in accordance with cGMP requirements Provide shop floor support, including clean room gowning, to support deviation investigations Support off‑shift activities as required to meet operational and investigation timelines Education
Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related scientific field Experience
0–3 years of post‑Bachelor’s experience in a cGMP pharmaceutical or biotechnology environment Examples include Production, Development, Process Engineering, or Technical Services Prior experience authoring deviation investigations for atypical manufacturing or laboratory events Familiarity with Lean Six Sigma methodologies and structured problem‑solving tools Additional Information
Strong analytical, problem‑solving, and critical‑thinking skills Demonstrated ability to work both independently and as part of cross‑functional teams Excellent written and verbal communication skills Role requires clean room gowning to support shop floor investigations and manufacturing support Off‑shift work may be required based on operational needs
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