Deviation Management Specialist

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.

• 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

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related scientific field

• 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

• 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