Deviation Management Specialist

Merck; North Wales (Montgomery County); On-site; USD 90,000 - 120,000; Full time

Job summary

Merck is seeking a detail-oriented Technical Support / Deviation Investigator Engineer to provide hands-on technical guidance for manufacturing operations. You will resolve process deviations, conduct root-cause investigations, and develop CAPAs, while collaborating across aseptic manufacturing, testing, planning, and batch release to ensure quality resolutions.

You will perform lab or pilot-scale experiments, document audit-ready reports, and apply Lean Six Sigma methods to improve yield and

Qualifications

• BS or MS in engineering or science.
• 1–3 years in a cGMP pharmaceutical/biotech environment.
• Experience writing investigation reports, root-cause analyses and CAPAs.

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 CAPAs 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.

Skills

Lean Six Sigma

Root-cause analysis

Technical writing

Analytical thinking

Education

BS or MS in engineering or science

Job description

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.