Lead Sterility Assurance Specialist

GE HealthCare•Arlington Heights, IL

10d•$95,040 - $142,560•Onsite

About The Position

Support sterility assurance functions to comply with regulations and support manufacturing operations. Responsible for planning/execution of multiple programs that support sterility assurance initiatives. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures.

Requirements

Bachelor’s degree in Microbiology or Biological Sciences from an accredited university or college.
Minimum of 4 years of experience in sterile pharmaceutical manufacturing.

Nice To Haves

Experience in parenteral drug manufacturing, preferably in Microbiology or Sterility Assurance.
Working knowledge of sterility assurance principles and global regulatory requirements (FDA, EU, Health Canada).
Understanding of aseptic manufacturing and terminal sterilization processes.
Strong written and verbal communication skills with the ability to independently plan, document, and execute protocols.
Ability to collaborate effectively across cross‑functional teams.

Responsibilities

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.
Author and execute protocols; coordinate testing with Manufacturing, QC Microbiology, and external laboratories; and review, analyze, and summarize program data and reports.
Implement and support deterministic CCI testing and ongoing program improvements.
Author, review, and troubleshoot investigations, SOPs, CAPAs, and Change Controls related to sterility assurance activities.
Support development and delivery of sterility assurance training for new employees and manufacturing teams.
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.
Support sterilization validations or qualifications and other site or project-based sterility assurance initiatives, as needed.
Participate in CCS quarterly and annual reviews to support continuous compliance and risk management.