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.
What You Need:
- 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).
This is an exciting opportunity to contribute to cutting-edge biopharmaceutical manufacturing while working in a collaborative and innovative environment.
