Deviation Management Specialist

TL;DR

Deviation Management Specialist (Pharma Manufacturing): Provide day-to-day technical support to manufacturing operations including resolution of process deviations, CAPA development, and leading investigations with an accent on troubleshooting atypical events and root cause analysis. Focus on applying scientific and engineering principles to investigate deviations, analyze complex problems through critical thinking, and implement corrective actions in a cGMP environment.

Onsite: West Point, PA 19486

$80,700 - $86,900

Company

Staffing agency placing specialists in Merck’s Manufacturing Division (MMD).

What you will do

• Provide technical support to manufacturing operations, resolving process deviations and developing/implementing corrective and preventative actions (CAPA).
• Lead manufacturing investigations for atypical events using scientific and engineering principles.
• Perform troubleshooting, root cause analysis, and analysis of complex problems.
• Build relationships with counterparts in aseptic manufacturing, testing, planning, and release areas.
• Support scientific needs within the manufacturing division; off-shift work may be required.

Requirements

• B.S./M.S. in engineering or scientific field.
• 0-3 years experience in cGMP environment (production, development, process engineering, technical services) in pharma/biotech.
• Experience writing investigations for atypical events in manufacturing.
• Familiarity with Lean Six Sigma methodologies and strong analytical/problem-solving skills.
• Ability to work independently and in cross-functional teams; excellent written/verbal communication.

Culture & Benefits

• Temporary assignments 13+ weeks with major medical, dental, vision, 401k, and statutory sick pay where required.
• Reasonable accommodations for disabilities.
• Equal opportunity employer committed to protected veterans and disabled individuals.
• Participates in E-Verify program as required by law.