Sterility Assurance Specialist: Contamination & Aseptic

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

Benefits offered by this job

Annual bonus

401(k) with match

PTO 20 days

Holidays 11

Health, dental, vision benefits

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, OH is seeking a Specialist, Sterility Assurance to support the site’s sterility assurance program.

The role collaborates with Manufacturing, QA, Microbiology, Engineering, and Validation to ensure regulatory compliance and continuous improvement in sterile manufacturing operations. Responsibilities include monitoring, investigations, data reviews, and timely environmental monitoring trend reports; coordinating CAPA, change control, and regulatory

Qualifications

• Bachelor's degree in Microbiology or relevant degree.
• 3–5 years of experience in sterile pharmaceutical manufacturing or related FDA-regulated environment.
• Experience supporting environmental monitoring programs and aseptic manufacturing operations.
• Knowledge of contamination control, cleanroom operations, and cGMP requirements.

Responsibilities

• Support site sterility assurance program maintenance and investigations.
• Coordinate environmental monitoring trend reports and remediation of issues.
• Provide sterility assurance support for media fill, EM, aseptic behavior, and sterilization processes.
• Assist with training on aseptic techniques and cleanroom behaviors.
• Support regulatory inspections and CAPA activities.

Skills

Sterility assurance

Environmental monitoring

Aseptic processing

Quality assurance

Documentation

Education

Bachelor's Degree in Microbiology

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, OH is seeking a Specialist, Sterility Assurance to support the site’s sterility assurance program.

The role collaborates with Manufacturing, QA, Microbiology, Engineering, and Validation to ensure regulatory compliance and continuous improvement in sterile manufacturing operations. Responsibilities include monitoring, investigations, data reviews, and timely environmental monitoring trend reports; coordinating CAPA, change control, and regulatory