Deviation Management Specialist

Summary
We are seeking a motivated and detail-oriented Deviation Management Specialist to join the manufacturing operations team within Merck’s Manufacturing Division (MMD). This individual will provide technical support for aseptic manufacturing, drive continuous improvement efforts, and conduct thorough investigations of atypical events. The ideal candidate will bring strong problem-solving skills and collaborate effectively across cross-functional teams.

Responsibilities
• Provide day-to-day technical support to aseptic manufacturing operations
• Lead and write manufacturing or laboratory investigations for atypical events
• Develop and implement corrective and preventative actions (CAPAs)
• Support product release, testing, and planning functions
• Collaborate with cross-functional teams to resolve manufacturing issues
• Conduct root cause analysis and troubleshoot process-related issues
• Apply scientific principles and execute laboratory or pilot-scale studies as needed
• Support process improvement initiatives using Lean Six Sigma methodologies
• Assist in resolving and reducing deviations in the manufacturing process
• Off-shift work may be required based on operational needs

Education
• B.S./M.S. degree in Engineering or a scientific field preferred
• Associate’s degree or no degree considered with relevant industry experience

Experience
• 0–3 years of post-Bachelor’s degree experience in a cGMP environment (Production, Development, Process Engineering, Technical Services, or related field)
• Prior experience in writing investigations in a manufacturing environment
• Familiarity with Lean Six Sigma principles
• Strong analytical and problem-solving abilities
• Proven ability to work both independently and collaboratively

Additional Information
• Temporary, 12 month assignment
• On-site role with potential off-shift work required
• Location: Merck Manufacturing Division (specific site details TBD)
• Ideal for individuals with a strong understanding of scientific or engineering processes and a passion for operational excellence