Senior Microbiology QC Lead - Investigations & Compliance

Merck Gruppe - MSD Sharp & Dohme; Ireland; Vor Ort; EUR 85.000 - 110.000; Vollzeit

Zusammenfassung

Merck Gruppe - MSD Sharp & Dohme is seeking a Microbiology QC Senior Specialist to provide technical leadership in QC Microbiology programs, environmental monitoring and clean utilities. You will coordinate investigations, CAPAs and regulatory readiness to support sterile manufacturing.

In this senior role, you will review complex data packages, qualify methods, lead cross-functional teams, and drive continuous improvement with new technologies.

Qualifikationen

• BSc or MSc in Microbiology, Biological Sciences or equivalent.
• 5–7 years of pharma/biotech lab experience with leadership
• Expertise in root cause investigations for environmental excursions, sterility failures or OOS results
• Extensive experience with cleanroom qualification and start-up activities
• Knowledge of CFR/Eudralex Annex 1, FDA/EMA guidance and compendial requirements for sterile products
• Strong technical writing for investigation reports and risk assessments
• Leadership, project management and cross-functional problem-solving skills
• Clear communication to summarize microbiological trends for site leadership
• Experience with Lean Six-Sigma to optimize lab workflows
• Excellent interpersonal and stakeholder influence skills

Aufgaben

• Provide advanced technical oversight of EM and clean utilities programs per regulatory expectations.
• Review complex lab records, validation data, transfer protocols and high-impact testing records.
• Author and facilitate microbiological investigations (sterility, bioburden, endotoxin) and ensure robust CAPAs.
• Participate in contamination control risk assessments (FMEA, HACCP) for cleanroom qualifications and VHP cycles.
• Oversee qualification of microbiological methods and QC lab equipment (autoclaves, isolators).
• Act as technical spokesperson for QC Microbiology during regulatory inspections (HPRA, FDA) and support inspection readiness.

Kenntnisse

Analytical Thinking

Bioburden Testing

Biological Indicators

Clean Rooms

Endotoxin Testing

Environmental Monitoring

Inspection Readiness

Quality Risk Assessment

Root Cause Analysis

Sterility Testing

Troubleshooting

Lean Six-Sigma

Ausbildung

B.Sc./M.Sc. in Microbiology or related field

Jobbeschreibung

Merck Gruppe - MSD Sharp & Dohme is seeking a Microbiology QC Senior Specialist to provide technical leadership in QC Microbiology programs, environmental monitoring and clean utilities. You will coordinate investigations, CAPAs and regulatory readiness to support sterile manufacturing.

In this senior role, you will review complex data packages, qualify methods, lead cross-functional teams, and drive continuous improvement with new technologies.