Merck · 12 hours ago
Deviation Management Specialist
North Wales, PA
Full-time
Onsite
New Grad, Entry Level
0+ years expMerck is a leading pharmaceutical company, and they are seeking a Deviation Management Specialist to provide technical and scientific support to manufacturing operations. The role involves investigating and resolving process deviations in a cGMP environment while collaborating with cross-functional teams to ensure product quality and compliance.
BiotechnologyHealth CareMedicalPharmaceutical
Hiring Manager
Stephanie Muse
Responsibilities
Provide daily technical support to manufacturing operations, including deviation identification, investigation, and resolution
Lead manufacturing and laboratory investigations for atypical events using structured root cause analysis methodologies
Develop, implement, and track corrective and preventive actions (CAPAs) to reduce recurrence of deviations
Troubleshoot laboratory test failures and manufacturing process anomalies
Apply critical analytical thinking to analyze complex problems and design/execute laboratory or pilot-scale experiments as needed
Partner with cross-functional teams supporting aseptic manufacturing, testing, planning, and product release
Develop and maintain strong working relationships with internal stakeholders across manufacturing and technical groups
Document investigations and outcomes clearly and compliantly in accordance with cGMP requirements
Provide shop floor support, including clean room gowning, to support deviation investigations
Support off-shift activities as required to meet operational and investigation timelines
Qualification
Required
Bachelor's or Master's degree in Engineering, Life Sciences, or a related scientific field
0–3 years of post-Bachelor's experience in a cGMP pharmaceutical or biotechnology environment
Examples include Production, Development, Process Engineering, or Technical Services
Prior experience authoring deviation investigations for atypical manufacturing or laboratory events
Familiarity with Lean Six Sigma methodologies and structured problem-solving tools
Strong analytical, problem-solving, and critical-thinking skills
Demonstrated ability to work both independently and as part of cross-functional teams
Excellent written and verbal communication skills
Role requires clean room gowning to support shop floor investigations and manufacturing support
Off-shift work may be required based on operational needs
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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