Senior QC Microbiology Lead & Innovation Advocate

MSD; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

MSD Malaysia is seeking a Microbiology QC Senior Specialist to provide technical leadership in EM and clean utility programs, while ensuring compliance with regulatory expectations. The role focuses on complex investigations, method transfers, and robust CAPA execution.

The candidate will review validation data, lead documentation, and represent QC Microbiology during regulatory inspections, driving continuous digital improvement across the lab.

Qualifications

• B.Sc. or M.Sc. in Microbiology or Biological Sciences (or equivalent).
• 5–7 years of pharma/biotech lab experience with leadership in investigations.
• Experience leading root cause investigations for environmental excursions, sterility failures or OOS results.

Responsibilities

• Provide advanced technical oversight of EM and clean utilities programs.
• Perform technical review of complex data packages and validation docs.
• Lead high-level microbiology investigations and ensure effective CAPAs.

Skills

Analytical Thinking

Bioburden Testing

Biological Indicators

Clean Rooms

Endotoxin Testing

Environmental Monitoring

Inspection Readiness

Microbiology

Quality Risk Assessment

Root Cause Analysis (RCA)

Sterility Testing

Troubleshooting

Education

B.Sc. or M.Sc. in Microbiology or Biological Sciences

Job description

MSD Malaysia is seeking a Microbiology QC Senior Specialist to provide technical leadership in EM and clean utility programs, while ensuring compliance with regulatory expectations. The role focuses on complex investigations, method transfers, and robust CAPA execution.

The candidate will review validation data, lead documentation, and represent QC Microbiology during regulatory inspections, driving continuous digital improvement across the lab.