Deviation Management Specialist

Education Requirements:

• B.S./M.S. degree in appropriate engineering or scientific field preferred
• AA degree or no degree will be considered with relevant experience

Experience Requirements:

• 0–3 years of post-Bachelor’s degree experience in a cGMP environment (Production, Development, Process Engineering, Technical Services, or related field) in the pharmaceutical/biotech industry
• Previous experience in writing investigations for atypical events in a manufacturing environment
• Familiarity with Lean Six Sigma methodologies and strong analytical/problem-solving skills
• Demonstrated ability to work independently and collaboratively within cross-functional teams
• Excellent written and verbal communication skills

Preferred Skills:

• Strong understanding of scientific and engineering principles
• Experience in aseptic manufacturing, testing, planning, and product release support
• Root cause analysis and troubleshooting experience
• Experience with laboratory/pilot-scale experiment design and execution

Responsibilities:

• Provide day-to-day technical support to manufacturing operations
• Resolve and reduce process deviations and lead manufacturing/laboratory investigations
• Develop and implement corrective and preventative actions (CAPAs)
• Provide scientific support for manufacturing areas within Merck’s Manufacturing Division (MMD)
• Develop strong cross-functional relationships with internal teams supporting aseptic operations
• Analyze complex problems using critical thinking and execute laboratory studies as needed
• Off-shift work may be required