Job Summary
The Technical Process Microbiologist plays a vital role in ensuring the microbiological control and assurance program is maintained within operations, adhering to corporate, cGMP, EHS, and other regulatory requirements.
Main Responsibilities
1. Set high standards of performance and compliance with Credo and Standards of Leadership.
2. Conduct activities in accordance with corporate, cGMP, EHS, and other regulatory requirements.
3. Lead process microbiological investigations and change controls, promoting a contamination awareness culture through open communication.
4. Perform routine area walkdowns and support process improvements to reduce contamination risks and enhance microbiological practices.
5. Regularly review key performance indicators of the contamination control program, providing timely communication of emerging trends as necessary.
6. Design and deliver training to support the site contamination control program.
7. Support capital project initiatives from a micro control perspective, maintaining customer focus to deliver business requirements.
8. Collaborate with Operations Process Microbiologists, the wider Operations team, and cross-functionally to achieve business goals.
9. Participate in planning for future requirements in Operations and relevant internal and external manufacturing-related audits.
10. Stay up-to-date with current regulatory trends and future testing requirements.
Requirements
Essential:
* Bachelor's degree in a scientific or technical discipline required.
* A minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
* Biomanufacturing knowledge and shop floor manufacturing process experience highly desirable.
* Working knowledge of data analytics.
* Familiarity with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Desirable:
* Experience as a manufacturing process specialist/process microbiologist within a Life Sciences or Biopharmaceutical manufacturing environment.
* Business Excellence and Problem Solving skills qualifications, e.g., Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
* Advanced degree (MS, MBA, PhD) preferred.