Lead Sterility Assurance Specialist

GE HealthCare UK

Arlington Heights, US
Base: $95,040.00-$142,560.00 annual; bonus/equity:...
Onsite
Aseptic manufacturing programs
Media fills and cci
Disinfectant efficacy testing
Manage site sterility assurance programs for aseptic manufacturing, including media fills, container closure integrity (CCI), and disinfectant efficacy, to ensure regulatory compliance and reliable operations

Job Summary

  • Manage site sterility assurance programs for aseptic manufacturing, including media fills, container closure integrity (CCI), and disinfectant efficacy, to ensure regulatory compliance and reliable operations.
  • Partner with the Sterility Assurance Program Manager to drive process improvements, align practices to industry standards, and address regulatory gaps related to Annex 1 and USP requirements.
  • GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

Matching Summary

Manage site sterility assurance programs for aseptic manufacturing, including media fills, container closure integrity (CCI), and disinfectant efficacy, to ensure regulatory compliance and reliable operations.

Salary

Base: $95,040.00-$142,560.00 Annual; Bonus/Equity: Performance based incentive compensation; Benefits: Medical, dental, vision, paid time off, 401(k), life, disability, accident insurance, tuition reimbursement

Skills & Requirements

Must-have

  • aseptic manufacturing programs
  • media fills and CCI
  • disinfectant efficacy testing
  • sterility assurance training
  • Annex 1 and USP compliance

Nice-to-have

  • parenteral drug manufacturing experience
  • cross-functional team collaboration
  • process improvement initiatives

Key Requirements

  • Bachelor’s degree in Microbiology or Biological Sciences
  • Minimum of 4 years of experience
  • sterile pharmaceutical manufacturing experience

Work Rights

Legally authorized to work in the United States

Tailored Resume

Cover Letter