Head Of Sterility Assurance

Lonza Group

Pearland, TX, US
Competitive compensation; performance-related bonu...
Onsite
Strong understanding of usp and ep sterility testing
Comprehensive knowledge of gmp regulations including 21cfr210/211
Hands-on experience in complex contamination control investigations
The Head of Sterility Assurance position at Lonza Group in Pearland, TX, is focused on leading the sterility assurance program to meet regulatory standards and enhance contamination control. The role requires close collaboration with site stakeholders and global quality teams to ensure compliance and improve operational effectiveness

Job Summary

  • This role is accountable for the compliant, effective, and modern contamination control strategy across the LHI site.
  • The position requires maintaining and updating aseptic education and awareness training programs to ensure sustainability.
  • Candidates will work closely with global stakeholders to align on best practices in sterility assurance and contamination control.

Matching Summary

Match Score: 85

The Head of Sterility Assurance position at Lonza Group in Pearland, TX, is focused on leading the sterility assurance program to meet regulatory standards and enhance contamination control. The role requires close collaboration with site stakeholders and global quality teams to ensure compliance and improve operational effectiveness.

Salary

Competitive compensation; Performance-related bonus; Medical, dental, vision, 401(k) matching, life insurance, disability, EAP, PTO

Skills & Requirements

Must-have

  • Strong understanding of USP and EP sterility testing
  • Comprehensive knowledge of GMP regulations including 21CFR210/211
  • Hands-on experience in complex contamination control investigations
  • Knowledge of microbiological test technologies and efficacy studies
  • Technical knowledge of clean room engineering and particle control

Nice-to-have

  • Experience with new product introduction and tech transfers
  • Ability to articulate technical aspects of risk assessments
  • Collaboration with global quality and MSAT stakeholders
  • Proactive assessment of environmental monitoring controls

Key Requirements

  • Strong regulatory understanding of environmental monitoring programs
  • Knowledge of ISO 9001:2015, 13485, and Part 11 compliance
  • Experience with EU Guidelines Annex 1 and FDA Guidance on Aseptic Processing

Work Rights

Not specified

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