Aseptic Sterility Excellence Specialist

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 45,000 - 75,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with match

20 days PTO

Personal days

Comprehensive benefits

Employee discount program

Career growth opportunities

Paid maternity and parental leave

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Specialist, Sterility Assurance in Bedford, OH to join our sterile manufacturing operations.

The role supports contamination control, environmental monitoring, aseptic processing, and microbiological quality systems to ensure GMP compliance and regulatory readiness. You will work with Manufacturing, QA, Microbiology, Engineering, Validation, and Maintenance on investigations, trends, CAPAs, and continuous improvement initiatives in sterile

Qualifications

• Bachelor’s Degree in Microbiology, or relevant degree and/or experience.
• Minimum: 3-5 years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, sterility assurance, or related FDA-regulated environments
• Experience supporting environmental monitoring programs and aseptic manufacturing operations
• Knowledge of cGMP requirements and regulatory expectations
• Strong technical writing, communication, and organizational skills

Responsibilities

• Support the site Sterility Assurance Program through routine monitoring and data review.
• Coordinate Environmental Monitoring Trend Reports and lead remediation of environmental issues.
• Assist with investigations, deviations, CAPAs, and change controls related to sterility.
• Support aseptic processing operations, media fills, gowning programs, and sterilization processes.
• Collaborate with Manufacturing, QA, Microbiology, Engineering, Validation, and Maintenance.

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Specialist, Sterility Assurance in Bedford, OH to join our sterile manufacturing operations.

The role supports contamination control, environmental monitoring, aseptic processing, and microbiological quality systems to ensure GMP compliance and regulatory readiness. You will work with Manufacturing, QA, Microbiology, Engineering, Validation, and Maintenance on investigations, trends, CAPAs, and continuous improvement initiatives in sterile