B.S./M.S. degree in an appropriate Engineering or Scientific field.
0–3 years of post-Bachelor's experience in a cGMP environment (Production, Development, Process Engineering, Technical Services, or a related field) within the pharmaceutical/biotech industry.
Experience writing investigations for atypical events in a manufacturing environment.
Familiarity with Lean Six Sigma methodologies and strong analytical/problem-solving skills.
Ability to work independently and collaboratively in a cross-functional team environment.
Excellent written and verbal communication skills.
Ideal candidate will have internship/co-op experience along with 1–2 years of industry experience.
Experience with manufacturing deviations/incidents and willingness to train on and conduct manufacturing investigations.
Provide day-to-day technical support to manufacturing operations.
Resolve and reduce process deviations through effective investigation and corrective actions.
Develop and implement Corrective and Preventive Actions (CAPA).
Lead manufacturing investigations and document findings.
Provide scientific and technical support for manufacturing areas within Merck's Manufacturing Division (MMD).
Build strong working relationships with teams supporting aseptic manufacturing, testing, planning, and product release.
Apply scientific and engineering principles to investigate process deviations.
Perform troubleshooting and root cause analysis for manufacturing atypical events.
Analyze complex problems using critical thinking and sound technical judgment.
Support off-shift activities as required.