On-Site: Sterilization SME/Laboratory SME (234674)

Clinical Research & Clinical Affairs | Life Sciences & Technology
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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)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
US On-Site

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