Description:
The client is looking for two (2) consultants with expertise in cleanrooms, contamination containment plan and cleanroom related policies/procedures development experience to support the set up of new internal and mobile cleanrooms.
- Work with core team to develop, complete and implement a contamination control plan for mobile cleanrooms.
- 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 relevant biocontamination control and cleanroom standards.
- Work with core team and management in defining gaps and implementing resolution plans.
- Work with core team to develop and complete a microbial risk assessment for the mobile cleanrooms.
- Revise and/or draft and implement procedures applicable to the contamination control plan for the expanded cleanrooms.
- Work with the core team to adapt the current cleaning and sanitization program for the expanded cleanrooms per ISO 14644-13.
- Revise and/or draft and implement procedures applicable to the contamination control plan for the new internal cleanrooms.
- Complete adoption of the cleanroom expansion changes into the existing dose audit program. Complete applicable product testing to show sustained compliance with the validation sterilization method per ISO 11137.
- Work with the core team and laboratory management to implement transferred testing equipment. Review equipment qualifications and confirm that standard requirements for microbiological test methods have been met.
- Perform other duties as required.
On-Site: Sterilization SME/Laboratory SME (234674)
