Senior Microbiologist, Aseptic QC & Contamination Lead

Alcon Laboratories Malaysia Sdn Bhd; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Alcon is seeking a Senior Associate (Senior Microbiologist) to lead advanced projects in the Quality Control Lab, focused on environmental monitoring, testing, and aseptic practices.

The role requires 5–8 years of GMP microbiology experience, strong contamination control knowledge, and the ability to drive investigations, CAPAs, and regulatory compliance across cross-functional teams. You will mentor staff and support site readiness for inspections.

Qualifications

• Bachelor's or Master's degree in Microbiology, Biological Sciences or Biotechnology.
• Minimum 5-8 years of microbiology experience in GMP-regulated environments.
• Strong knowledge of aseptic processing and contamination control.
• Experience with Environmental Monitoring and cleanroom microbiology.
• Proven experience conducting microbiological investigations and root cause analysis.
• Knowledge of FDA, EU GMP Annex 1, PIC/S and Data Integrity requirements.
• Extensive experience in microbiological control of Grade A/Grade B aseptic areas.

Responsibilities

• Serve as the microbiology SME for aseptic manufacturing, contamination control, and microbiological QA.
• Manage environmental monitoring and microbiological testing programs for cleanrooms.
• Support validation, qualification, and routine microbiological assessments.
• Drive decisions on microbiological investigations, risk assessments, and CAPAs.
• Collaborate with Manufacturing, Quality, Engineering and Validation to meet site objectives.
• Lead investigations of microbiological excursions and implement CAPAs.
• Ensure compliance with cGMP, GxP, regulatory expectations and site procedures.
• Review and approve microbiology results, procedures, protocols, and reports.
• Provide microbiological training and mentor junior staff.
• Support qualification of analysts and aseptic operators.
• Ensure data integrity and GMP compliance in the microbiology lab.
• Support Contamination Control Strategy and risk assessments for processes.
• Drive contamination investigations and root cause analyses.
• Partner with cross-functional teams to improve contamination prevention.
• Provide microbiological expertise to site personnel.

Skills

Aseptic processing

Environmental monitoring

Microbiology expertise

Root cause analysis

CAPA investigations

Regulatory knowledge

Contamination control

Education

Bachelor's or Master's in Microbiology / Biological Sciences / Biotechnology

Job description

Alcon is seeking a Senior Associate (Senior Microbiologist) to lead advanced projects in the Quality Control Lab, focused on environmental monitoring, testing, and aseptic practices.

The role requires 5–8 years of GMP microbiology experience, strong contamination control knowledge, and the ability to drive investigations, CAPAs, and regulatory compliance across cross-functional teams. You will mentor staff and support site readiness for inspections.