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Principal Sterility Assurance Specialist

Pride Global

Eagan, MN

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JOB DETAILS
SALARY
$45–$50 Per Hour
SKILLS
Analysis Skills, Continuous Improvement, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Environmental Monitoring, FDA (Food and Drug Administration), Maintain Compliance, Manufacturing Requirements, Medical Organizations, Mentoring, Microbiology, Process Improvement, Project Lifecycle, Project/Program Management, Quality Engineering, Regulations, Research & Development (R&D), Root Cause Analysis, Standard Operating Procedures (SOP), Sterilization, Team Player, Technical Leadership, Technical Writing, Test Program, Trend Analysis, Validation Plan, Vendor/Supplier Evaluation, Writing Skills
LOCATION
Eagan, MN
POSTED
3 days ago
The Science Team at Russell Tobin and Associates is hiring a "Principal Sterility Assurance Specialist" for a top leading medical technology organization.

Key Responsibilities
  • Lead sterility assurance programs, sterilization validations, and cycle development projects.
  • Partner with R&D, Quality, Regulatory Affairs, Manufacturing, and suppliers to ensure product compliance.
  • Support environmental monitoring, bioburden, sterility, endotoxin, and EO residual testing programs.
  • Lead investigations, root cause analyses, and corrective actions related to sterility assurance issues.
  • Author and review validation protocols, technical reports, SOPs, and quality documentation.
  • Support regulatory inspections, supplier audits, and compliance assessments.
  • Analyze microbiological and environmental monitoring trends and drive continuous improvement initiatives.
  • Train and mentor sterility assurance personnel and provide technical leadership across projects.
Qualifications
  • Bachelor's degree in a scientific or engineering discipline; Master's degree preferred.
  • 8+ years of experience in sterility assurance, microbiology, quality, engineering, or related technical fields.
  • Strong knowledge of sterilization standards, cGMP, GDP, and FDA-regulated environments.
  • Excellent technical writing, project management, analytical, and cross-functional collaboration skills.
Additional Information:
  • Pay: $45–$50/hour
  • Contract: 4 months with potential extension
  • Location: Eagan, MN 55121
Must be authorized to work in the United States. 
 
APPLY NOW!
 
Pride Global and its affiliates, including Russell Tobin, Pride Health, Pride Now, and Pride One, offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity
Pride Global and its affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
 
Fair Chance Employment
Pride Global and its affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.
 
Accommodations
We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us. 
 
Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

#LI-RA1
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About the Company

P

Pride Global

Pride Global is a minority-owned integrated human capital solutions firm headquartered in New York with operating companies throughout the United States, Canada, India and Brazil. Pride Global companies focus on a diverse array of services including vendor management, payroll programs, business process optimization, and staffing for both direct hire and contingent labor.

COMPANY SIZE
100 to 499 employees
INDUSTRY
Financial Services
FOUNDED
1983
WEBSITE
http://prideglobal.com

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