Senior Process Microbiologist: Contamination Control & QA

Get 360Pharma; Leiden; On-site; EUR 70,000 - 100,000; Full time

Job summary

Janssen Biologics in the Netherlands is seeking a Process Microbiologist within the Quality Assurance department to strengthen the microbiology and contamination control program for lentiviral product production in a controlled cGMP cleanroom.

The role requires a strong background in microbiology, cGMP compliance, and collaboration across QA, QC, operations and maintenance to develop contamination control strategies, perform investigations, and train staff.

Qualifications

• BSc or MSc in science, preferably Microbiology.
• At least 6 years in biopharmaceutical production/quality.
• Experience with microbial contamination control in pharma.
• Excellent English communication, written and spoken.

Responsibilities

• Ensure contamination control aligns with cGMP and regulations (e.g., EUDRALEX Annex 1/2).
• Review facility changes related to design, maintenance, gowning, cleaning, and testing for microbiological control.
• Lead microbiology training programs including aseptic operator training.
• Design, qualification/validation, and maintenance of aseptic techniques and related studies.
• Identify contamination risks and drive shop-floor improvements with operators and management.
• Support investigations and contamination task forces; participate in environmental monitoring oversight.
• Maintain current knowledge of regulations and industry trends in contamination control.
• Collaborate with QC Microbiology, QA, Compliance and Operations.

Skills

Microbiology

cGMP

Training

English

Education

BSc/MSc in Microbiology

Job description

Janssen Biologics in the Netherlands is seeking a Process Microbiologist within the Quality Assurance department to strengthen the microbiology and contamination control program for lentiviral product production in a controlled cGMP cleanroom.

The role requires a strong background in microbiology, cGMP compliance, and collaboration across QA, QC, operations and maintenance to develop contamination control strategies, perform investigations, and train staff.