Collabera · 1 day ago
Microbiology and Sterilization Scientist
Collabera is a company that provides global microbiology support for medical device combination products within a regulated manufacturing environment. The role involves offering scientific guidance, supporting validation activities, and contributing to regulatory documentation and submissions.
Responsibilities
Provide global microbiology support for medical device combination products
Consult on technical issues and troubleshoot microbiology-related challenges
Author, review, and support regulatory submissions for global health authorities
Review investigation reports and contribute scientific input to validation activities
Manage assigned microbiology projects from initiation through completion
Develop, author, and validate microbiological testing methods
Collaborate with subject matter experts and internal teams on validation and documentation efforts
Provide microbiology expertise for investigations, deviations, and corrective actions
Qualification
Required
Bachelor's degree in Microbiology or a related scientific discipline
Strong microbiology background within a pharmaceutical or medical device manufacturing environment
Hands-on experience with sterility assurance or sterilization modalities
Working knowledge of sterilization methods including moist heat, dry heat, gamma radiation, or electron beam
Experience with microbiological test methods aligned with United States Pharmacopeia chapters <51>, <61>, <71>, and <85>, or equivalent international standards
Knowledge of international standards related to sterilization and microbiological testing
Proven experience in microbiology method writing, validation, and troubleshooting
Strong documentation skills within a regulated environment
Preferred
Master's degree in Microbiology or a related field with relevant industry experience
Familiarity with biological indicators
Experience supporting global regulatory submissions and interacting with regulatory agencies
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking or public transportation
Paid time off
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually – as applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Recent News
2024-04-09
2023-01-20
2022-04-19
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