Gamma and Steam Sterilization Review/Clean Room Gap Assessment (232495) Remote

Engineering Services | Healthcare IT | Life Sciences & Technology


Duration: Will be working on a project basis, each project will be sent over and an estimated number of hours will be agreed upon.

Start Date: ASAP

Job Description:
1. Annual Gamma Sterilization Family Review
2. Annual Steam Sterilization Family Review
3. Bioburden change review (closely related to 1)
4. Redline updates to clean room SOP(s) for standards compliance (gap assessments for ISO 14644 & ISO 17141)
5. Review and evaluation of microbial identification data
6. Review and evaluation of CEA excursions/limit violations

Skills: Clean Room, Gamma Sterilization, Steam Sterilization, Bioburden Testing, Microbiology, ISO 14644, ISO 17141

Education: Experience outweighs degree.


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
Remote, United States

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