Senior QC Microbiology — 24/7 Cleanroom Ops

Aphex Group; Leinster; On-site; EUR 65,000 - 75,000; Full time

Job summary

Aphex Group, in Ireland, seeks a Senior QC Microbiology specialist to support manufacturing on a 24/7 shift pattern. The role emphasizes environmental monitoring of Grade 8/9 and Grade 5/7 cleanrooms, reading EM plates, and bioburden testing of water and disinfectants, within a cGMP framework.

You will generate technical reports, work with LIMS/LMES, Trackwise and SAP, and interact with regulatory inspectors.

Qualifications

• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical product
• Aseptic cleanroom experience for Environmental Monitoring.
• Proficient with LIMS & LMES.
• Strong microbiology and aseptic manufacturing background.
• Experience with regulatory inspectors desirable.
• Ability to deliver right-first-time results.
• Ability to work with changing priorities on a daily basis.

Responsibilities

• Environmental Monitoring of Grade 8/9 Cleanrooms.
• Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators.
• Reading of Environmental Monitoring Plates.
• Bioburden testing of water & disinfectants.
• Writing technical reports such as monthly and annual EM trend reports.
• Testing of In Process samples such as pH.
• Testing of Biological Indicators.

Skills

Microbiology lab experience

Aseptic manufacturing

Independent worker

Regulatory compliance

Environmental monitoring

Tools

LIMS

LMES

Trackwise

SAP

CDOCS

Job description

Aphex Group, in Ireland, seeks a Senior QC Microbiology specialist to support manufacturing on a 24/7 shift pattern. The role emphasizes environmental monitoring of Grade 8/9 and Grade 5/7 cleanrooms, reading EM plates, and bioburden testing of water and disinfectants, within a cGMP framework.

You will generate technical reports, work with LIMS/LMES, Trackwise and SAP, and interact with regulatory inspectors.