What are the responsibilities and job description for the Deviation Management Specialist position at Merck?
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 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
- 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-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
Salary : $39 - $41