Senior Microbiologist

Senior Microbiologist (Cleanroom Expert)

Location –Cordova, TN Plant

Travel will be required (25%ish)

Remote role – on-site time required (travel paid)

M-F Normal Business Hours

Senior Microbiologist Role Responsibilities

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

cleanrooms.

• 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.

• Perform gap analysis between leveraged site procedures and ISO 14698, BS EN 17141, and ISO
  
  

14644-1-4.

• Work with core team and management in defining gaps and implementing resolution plans.
• Work with the core team to develop a cleaning and sanitization program for the mobile cleanrooms per
  
  

ISO 14644-13.

• Work with core team to develop a material management program for the mobile cleanrooms.
• Work with core team to develop a gowning program for the mobile cleanrooms.
• Work with core team to develop and complete a risk assessment for the mobile cleanrooms.
• Revise and/or draft and implement procedures applicable to the contamination control plan for the
  
  

mobile cleanrooms.

• Work with the core team to develop, complete and implement a contamination control plan for the
  
  

current and new internal cleanrooms.

• Work with the core team to adapt current cleaning and sanitization program for the new internal
  
  

cleanrooms per ISO 14644-13.

• Revise and/or draft and implement procedures applicable to the contamination control plan for the
  
  

new internal cleanrooms.

• Report into core team providing status updates for projects.
• Manage timely & consistent communications with Project Management leadership.
  
  

Additional Duties

• 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.

• Begin development of contamination control plan. Complete trace matrix and gap assessments. Begin
  
  

development of cleaning/sanitization, gowning and material management programs.

• Continue work with core team for the completion of new and developed procedures. Complete risk
  
  

assessment and EM sampling program.

• Continue work with the core team to support start up of manufacturing of mobile cleanrooms and new
  
  

internal cleanrooms.