Deviation Management Specialist

WorkLLama; West Point (MS); Vor Ort; USD 70.000 - 95.000; Vollzeit

Zusammenfassung

Merck seeks a detail-oriented Technical Support / Deviation Investigator Engineer to guide manufacturing operations with hands-on technical support and leadership in investigations.

You will perform root cause analyses, develop CAPAs, and collaborate with aseptic manufacturing, QA, and planning teams to maintain quality and efficiency on the plant floor.

Qualifikationen

• BS or MS in engineering or scientific field.
• 1–3 years in a cGMP environment (pharma/biotech).
• Experience in writing investigation reports, root-cause analyses, and CAPAs.

Aufgaben

• Provide real-time, on-the-floor technical and scientific support across active manufacturing areas.
• Lead comprehensive investigations for manufacturing atypical events and laboratory test failures.
• Perform thorough root-cause analysis using structured problem-solving frameworks.
• Develop, implement, and track CAPA to mitigate risk and reduce deviations.
• Design, execute, and analyze lab or pilot-scale experiments to evaluate process challenges.
• Collaborate cross-functionally with aseptic manufacturing, testing, planning, and batch release teams.
• Author audit-ready investigation reports, CAPA documentation, and process assessments.
• Apply Lean Six Sigma methodologies to improve process consistency and yield.

Kenntnisse

Root cause analysis

CAPA development

Technical writing

Lean Six Sigma

Analytical thinking

Cross-functional collaboration

Ausbildung

BS or MS in engineering or scientific field

Jobbeschreibung

Summary We are seeking a detail-oriented Technical Support / Deviation Investigator Engineer to provide hands-on technical guidance for manufacturing operations within Merck’s Manufacturing Division (MMD). In this role, you will be responsible for resolving process deviations, conducting root-cause investigations for atypical manufacturing or laboratory events, and developing effective Corrective and Preventive Actions (CAPA). Working both independently and across cross-functional teams supporting aseptic manufacturing, you will apply sound scientific and engineering principles alongside Lean Six Sigma methodologies to analyze complex problems and maintain high quality and operational efficiency.

Responsibilities

• Provide real-time, on-the-floor technical and scientific support across active manufacturing areas.
• Lead comprehensive investigations for manufacturing atypical events and laboratory test failures.
• Perform thorough root-cause analysis using structured problem-solving frameworks to identify underlying issues.
• Develop, implement, and track Corrective and Preventive Actions (CAPA) to mitigate risk and reduce future process deviations.
• Design, execute, and analyze laboratory or pilot-scale experiments to evaluate complex process challenges.
• Collaborate cross-functionally with teams across aseptic manufacturing, testing, planning, and batch release to align on quality resolutions.
• Author detailed, audit-ready technical investigation reports, CAPA documentation, and process assessments.
• Leverage Lean Six Sigma methodologies and analytical thinking to continuously improve process consistency and yield.

Education

• Bachelor of Science (BS) or Master of Science (MS) degree in an appropriate engineering or scientific field.

Experience

• Minimum of 1–3 years of experience in a cGMP environment (e.g., Production, Process Engineering, Technical Services, Development, or related pharmaceutical/biotech fields); relevant academic research or industry internship experience is accepted.
• Proven experience in technical writing, specifically writing investigation reports, root-cause analyses, and CAPAs in a manufacturing setting.
• Familiarity with Lean Six Sigma methodologies and structured problem-solving tools.
• Strong background applying critical analytical thinking to complex scientific/engineering problems.

Additional Information

• Work Environment: Requires active presence on the manufacturing floor and collaboration across cross-functional cGMP operations.
• Core Competencies: Excellent technical/scientific writing, robust verbal communication skills, strong interpersonal collaboration, and the ability to work independently in a fast-paced environment.