Sterility Assurance Scientist

Job Title: Sterility Assurance Scientist
Company: Intellectt Inc
Location: Charlotte Area, NC
Pay: $50/hr on W2
Work Environment: Onsite

Job Summary:
Seeking an experienced Sterility Assurance Scientist to support aseptic pharmaceutical manufacturing, contamination control, and sterility assurance activities in a GMP-regulated environment.

Key Responsibilities

• Provide hands-on aseptic processing and cleanroom support.
• Monitor gowning practices, aseptic techniques, and contamination control.
• Investigate deviations, perform root cause analysis, and implement CAPAs.
• Support environmental monitoring, smoke studies, media fills, and qualification activities.
• Troubleshoot manufacturing issues and analyze microbial and environmental data.
• Train operators and collaborate with Manufacturing, Quality, and Technical Services.

Required Qualifications:

• Bachelor's degree in Microbiology, Biology, Chemistry, or a related field.
• Experience in GMP pharmaceutical/biopharmaceutical manufacturing, preferably parenteral or aseptic filling.
• Strong knowledge of sterility assurance, aseptic processing, and environmental monitoring.
• Hands-on experience with deviations, RCA, and CAPA.
• Ability to work in classified cleanrooms and rotating 12-hour night shifts.

Preferred: 5+ years of experience in Sterility Assurance, MSAT, Environmental Monitoring, or aseptic manufacturing. Experience with media fills, smoke studies, isolators, Veeva Vault, or TrackWise is a plus.

Name: Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

Benefits:
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws