Collabera · 1 day ago
Sterilization Microbiologist
Plymouth, MN
Contract
Onsite
Entry Level
$25/hr - $32/hr
1+ years expCollabera is a company working with a Medical Devices client, and they are seeking a Sterilization Microbiologist. The role involves reviewing and interpreting cleanroom monitoring results, documenting and investigating excursions, and providing biological support to sterilization-related activities.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Siddhi Kadakia
Responsibilities
Perform a desk-based role with no hands-on laboratory or cleanroom work required
Review and interpret cleanroom monitoring results, including:
Non-viable particle counts
Viable active air monitoring
Viable surface monitoring
Pressure differentials and alarms
HEPA airflow and velocity
Electronically review routine test results in LIMS, including:
Environmental monitoring data
Product bioburden results
Product endotoxin results
Document and investigate cleanroom monitoring excursions when results do not meet specifications
Document and investigate environmental disturbances within cleanroom environments (e.g., pressure differential excursions)
Document and investigate product bioburden and endotoxin excursions, including identification of potential root causes
Support Supplier Change Notifications (SCN) by evaluating supplier-initiated changes and assessing potential impact to:
Product bioburden
Bacterial endotoxin
Sterilization processes
Support changes to the manufacturing environment by authoring Environmental Disturbance Reports (EDRs) for planned activities such as:
Adding equipment
Adding tables or personnel
Other manufacturing layout or process changes
Author technical reports for acceptable results and ensure accurate documentation and approvals
Conduct cross-functional investigations and discussions with Engineers, Production Supervisors, and other stakeholders (e.g., via MS Teams)
Focus on data review, investigation, documentation, and approval activities only
Provide biological support to sterilization-related activities (no hands-on sterilization work)
After initial training, work independently with minimal oversight and take ownership of assigned investigations
Qualification
Required
Bachelor's degree in Microbiology, Biology, Life Sciences, or a related scientific field plus 1+ year of relevant experience, or an equivalent combination of education and experience
Knowledge of medical device manufacturing and cleanroom environments
Familiarity with ISO Class 6-9 cleanrooms (ISO 8 and ISO 9 preferred)
Basic working knowledge of bioburden and endotoxin testing, including common causes of elevated results
Strong analytical, documentation, and investigation skills
Ability to work confidently, independently, and manage investigations once trained
Preferred
Endotoxin testing experience is highly preferred
LIMS experience is helpful but not required (training will be provided)
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
10001+ employees
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
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2024-04-09
2023-01-20
2022-04-19
Company data provided by crunchbase