Microbiology Specialist

Core Skills:

• Strong cross-functional troubleshooting, communication, and negotiation skills
• Master’s or Ph.D. in Science/Engineering
• Experience in cGMP investigations within pharmaceutical manufacturing (OSD preferred)

Key Responsibilities

• Lead/develop cGMP investigations for OSD manufacturing deviations, nonconformances, and atypical events
• Perform root cause analysis using tools like 5-Why, Fishbone, and Fault Tree
• Review manufacturing, engineering, and QC data (MES, LIMS, SCADA, historian tools, batch records, etc.)
• Coordinate with QA, QC, Engineering, and Operations for event triage, containment, CAPA, and batch disposition
• Author investigation reports, CAPAs, product impact assessments, and support audit readiness

Preferred Experience

• OSD processes: blending, granulation, compression, coating, encapsulation
• eQMS, MES, LIMS, deviation/CAPA systems, trending tools, AI tools
• OOS/OOT investigations, GDP documentation, data integrity, and pharmaceutical quality systems

Key Traits

Strong analytical/problem-solving skills, ability to manage multiple investigations, interpret manufacturing/lab data, and proactively drive resolutions in cross-functional environments.