Specialist, Sterility Assurance

Job Title:

Specialist, Sterility Assurance

Location:

Bedford, OH
Job Type: Full-Time
Req
About UsAs a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description The Specialist, Sterility Assurance supports the site Sterility Assurance Program by providing technical expertise in contamination control, environmental monitoring, aseptic processing, and microbiological quality systems. This individual works closely with Manufacturing, Quality Assurance, Microbiology, Engineering, Validation, and Maintenance to support routine monitoring, investigations, compliance activities, and continuous improvement initiatives related to sterile manufacturing operations.

The Specialist is responsible for supporting the maintenance of site sterility assurance programs, assisting with investigations, reviewing data and trends, and ensuring activities comply with current GMP and regulatory requirements.

The individual shall be responsible for coordinating the timely completion of Environmental Monitoring Trend Reports and lead the remediation of environmental issues. Responsible for making Quality decisions related to Sterility Assurance for manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.

Key Responsibilities

• Support the site's Contamination Control Strategy (CCS) through routine monitoring, data review, and continuous improvement activities.
• Provide sterility assurance support for:
  • Media Fill (Aseptic Process Simulation) Program
  • Environmental Monitoring (EM) Program
  • Aseptic Behavior and Gowning Programs
  • Sterilization and Sanitization Processes
  • Personnel, material, and product flow assessments within classified areas
• Participate in investigations related to environmental monitoring excursions, contamination events, media fill failures, and other sterility assurance concerns.
• Review and assess deviations, CAPAs, and change controls for potential sterility assurance impact.
• Assist in the evaluation of classified manufacturing areas to ensure compliance with facility fit-and-finish requirements.
• Support generation and review of environmental monitoring trend reports and annual assessments.
• Review environmental monitoring data and elevate adverse trends as appropriate.
• Collaborate with Manufacturing, Quality Assurance, and Microbiology teams to support aseptic processing operations.
• Assist with training activities related to aseptic techniques, gowning practices, cleanroom behaviors, and contamination prevention.
• Support maintenance of sterility assurance procedures, policies, and documentation to ensure compliance with regulatory expectations and industry best practices.
• Participate in internal audits, regulatory inspections, and client audits as a sterility assurance technical resource.
• Support microbiological method qualification and monitoring activities, as applicable.
• Assist in ensuring media fill programs adequately represent manufacturing operations, interventions, and aseptic process requirements.
• Support environmental monitoring activities to ensure personnel, facilities, and processes remain in…