Sterility Assurance Scientist

Preferred Experience: 5+ years in Sterility Assurance, MSAT/MS&T, Environmental Monitoring, or Parenteral Manufacturing, with experience in APS/media fills, smoke studies, EMPQs, and commercial pharmaceutical operations. Job Summary: Seeking a Sterility Assurance Scientist with hands-on experience in GMP-regulated sterile pharmaceutical or biopharmaceutical manufacturing, particularly aseptic parenteral drug production.

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity Sterility Assurance Scientist Night Shift based Charlotte, NC (On-Site), at one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

mahalakshmi.n@intellectt.com

OR +1 (732) 737 8381

Job Title: Sterility Assurance Scientist Night Shift

Location: Charlotte, NC

Duration: 12+ Months

Rate: $40/hr

Schedule: Rotating 12-hour night shifts (2-2-3 schedule); initial training on day shift.

Job Summary: Seeking a Sterility Assurance Scientist with hands-on experience in GMP-regulated sterile pharmaceutical or biopharmaceutical manufacturing, particularly aseptic parenteral drug production. The role involves cleanroom floor support, aseptic technique monitoring, contamination control, troubleshooting, deviation investigations, root cause analysis, and CAPA management.

Key Responsibilities:

• Provide hands-on aseptic manufacturing floor support and coach operators on gowning and aseptic techniques.
• Support environmental monitoring, contamination control, smoke studies, media fills (APS), and validation activities.
• Lead deviation investigations, root cause analysis, and CAPA implementation.
• Support cleaning, sanitization, isolator glove integrity, and contamination investigations.
• Collaborate with Manufacturing, QA, Engineering, and Technical Services teams.

Required Skills:

• Strong GMP, aseptic processing, microbiology, and sterility assurance knowledge.
• Experience in deviation investigations, RCA, and CAPA.
• Hands-on sterile manufacturing floor experience.
• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Ability to work in classified cleanrooms and rotating 12-hour night shifts.

Preferred Experience: 5+ years in Sterility Assurance, MSAT/MS&T, Environmental Monitoring, or Parenteral Manufacturing, with experience in APS/media fills, smoke studies, EMPQs, and commercial pharmaceutical operations.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
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
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.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com