Senior Microbiology QC Lead — Investigations & Tech Transfer

Msd Ireland; Leinster; On-site; EUR 75,000 - 110,000; Full time

Job summary

MSD Ireland is seeking a Microbiology QC Senior Specialist to provide technical leadership for QC Microbiology programs, EMS and clean utilities. The role coordinating advanced investigations, CAPAs and regulatory readiness supports sterile manufacturing compliance and technology transfers.

You will drive risk assessments, oversee validation activities and contribute to continuous improvement with a focus on Annex 1 compliance and rapid micro methods advancements.

Qualifications

• Degree in Microbiology or biology-related field.
• 5–7 years of pharma/biotech lab experience with leadership.
• Proven track record in complex investigations (sterility, bioburden).
• Experience with cleanroom qualification and regulatory expectations (Annex 1).
• Advanced technical writing, risk assessment and RCA capability.

Responsibilities

• Provide advanced technical oversight of EM and clean utilities programs.
• Perform critical technical reviews of records and protocols.
• Lead microbiology investigations and CAPA activities.
• Participate in risk assessments and site qualification decisions.
• Oversee method qualification and tech transfer activities.
• Represent QC Microbiology in regulatory inspections.
• Drive continuous improvement and digital lab innovations.
• Author and pre-approve complex technical documentation.

Skills

Technical leadership

Root cause investigations

Environmental Monitoring

Cleanroom qualification

Regulatory knowledge

Technical writing

Project management

Communication

Lean Six Sigma

Troubleshooting

Education

B.Sc. or M.Sc. in Microbiology or equivalent

Tools

Autoclaves

Isolators

Bioburden testing

Job description

MSD Ireland is seeking a Microbiology QC Senior Specialist to provide technical leadership for QC Microbiology programs, EMS and clean utilities. The role coordinating advanced investigations, CAPAs and regulatory readiness supports sterile manufacturing compliance and technology transfers.

You will drive risk assessments, oversee validation activities and contribute to continuous improvement with a focus on Annex 1 compliance and rapid micro methods advancements.