Senior Microbiologist Cleanroom

Senior Microbiologist Role Responsibilities:

1. Work with core team to develop, complete and implement a contamination control plan for mobile cleanrooms.

2. Develop and complete trace matrix to determine which internal procedures can be leveraged from current site procedures and which need development for the contamination control plan.

3. Perform gap analysis between leveraged site procedures and ISO 14698, BS EN 17141, and ISO (phone number removed)-4.

4. Work with core team and management in defining gaps and implementing resolution plans.

5. Work with the core team to develop a cleaning and sanitization program for the mobile cleanrooms per ISO (phone number removed).

6. Work with core team to develop a material management program for the mobile cleanrooms.

7. Work with core team to develop a gowning program for the mobile cleanrooms.

8. Work with core team to develop and complete a risk assessment for the mobile cleanrooms.

9. Revise and/or draft and implement procedures applicable to the contamination control plan for the mobile cleanrooms.

10. Work with the core team to develop, complete and implement a contamination control plan for the current and new internal cleanrooms.

11. Work with the core team to adapt current cleaning and sanitization program for the new internal cleanrooms per ISO (phone number removed).

12. Revise and/or draft and implement procedures applicable to the contamination control plan for the new internal cleanrooms.

13. Report into core team providing status updates for projects.

14. Manage timely & consistent communications with Project

Management leadership.

15. Perform other duties as required.

1. Completing on boarding, including: completion of training for cleanroom expansion activities. Integrate with core team and site representatives.

Knowledge of site specific procedures relevant to manufacturing, environmental monitoring and contamination control.

2. Begin development of contamination control plan.

Complete trace matrix and gap assessments. Begin development of

cleaning/sanitization, gowning and material management programs.

3. Continue work with core team for the completion of new and

developed procedures. Complete risk assessment and EM sampling

program.

4. Continue work with the core team to support start up of

manufacturing of mobile cleanrooms and new internal cleanrooms.