Deviation Management Specialist - I

We are seeking a motivated and detail-oriented professional to join our team within Merck’s Manufacturing Division (MMD). This role provides critical technical support to manufacturing operations, ensuring processes run efficiently and in compliance with cGMP standards. The position offers the opportunity to work cross-functionally, contribute to investigations, and apply scientific and engineering expertise to improve operations.

Responsibilities

• Provide day-to-day technical support to manufacturing operations, including troubleshooting, deviation resolution, and process improvement.
• Lead investigations into manufacturing and laboratory atypical events, utilizing sound scientific and engineering principles.
• Develop and implement effective corrective and preventative actions (CAPAs) to reduce and prevent process deviations.
• Conduct root cause analyses of laboratory test failures and manufacturing events.
• Perform critical data analysis and design/execute laboratory or pilot-scale experiments to address complex problems.
• Collaborate with cross-functional partners in aseptic manufacturing, testing, planning, and product release.
• Support Lean Six Sigma initiatives and continuous improvement efforts.
• Availability for off-shift work as required.

Qualifications

• B.S. or M.S. degree in an appropriate engineering or scientific field.
• 0–3+ years of post-bachelor’s experience in a cGMP environment (e.g., production, development, process engineering, technical services, or related field) in the pharmaceutical/biotech industry.
• Previous experience writing investigations for atypical manufacturing events.
• Familiarity with Lean Six Sigma methodologies and strong problem-solving/analytical capabilities.
• Demonstrated ability to work independently and collaboratively in cross-functional teams.
• Excellent written and verbal communication skills.