About the Job
We are seeking a Process Microbiologist to support microbiological control and assurance in a GMP-regulated operations environment. This role involves process investigations, risk assessments, contamination prevention strategies, and environmental monitoring to maintain the highest microbiological standards in manufacturing.
Key Responsibilities:
* Lead and support microbiological investigations and contamination risk reduction initiatives.
* Conduct routine walkdowns, GEMBA activities, and process risk assessments.
* Ensure compliance with cGMP, EHS, and regulatory requirements.
* Review environmental monitoring data and implement corrective actions.
* Collaborate with internal teams and global microbiology support networks.
* Support audits, regulatory trends, and manufacturing process improvements.
Requirements:
* BSc in Biology or a related scientific field (Advanced degree preferred).
* 3-5 years' experience in pharmaceutical or GMP-regulated operations.
* Strong understanding of FDA/EMEA regulatory requirements.
* Knowledge of data analytics, process validation, and risk management.
* Six Sigma, Lean, or problem-solving certifications (desirable).
About You
This is an exciting opportunity to contribute to cutting-edge biopharmaceutical manufacturing while working in a collaborative and innovative environment.