Sterility Assurance Scientist

Insight Global; Concord (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Insight Global is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. The role acts as a technical resource on the manufacturing floor, guiding aseptic processing, contamination control, environmental monitoring, and cleanroom best practices.

Responsibilities include investigations, CAPAs, and process improvements while partnering with Operations, Quality, Engineering and Technical Services to ensure compliance with GMP and aseptic

Qualifications

• Bachelor's degree in a scientific discipline (Microbiology/Biology/Chemistry/Biochemistry/Pharmaceutical Sciences)
• 5+ years of experience in pharmaceutical/biopharmaceutical manufacturing
• Experience in sterile, aseptic, parenteral, or injectable product manufacturing
• Strong understanding of contamination control and sterility assurance
• Experience with investigations, root cause analysis, deviations, and CAPA activities
• Hands-on GMP manufacturing support on the floor
• Cross-functional collaboration with Manufacturing, Quality, Engineering, and Operations
• Ability to work in cleanroom environments and provide floor-based support

Responsibilities

• Support sterile/parenteral manufacturing operations on the floor.
• Provide hands-on technical guidance on aseptic processing and sterility assurance.
• Collaborate with Operations, Quality, Environmental Monitoring, Engineering and Technical Services.

Skills

Aseptic processing

Sterility assurance

Environmental monitoring

CAPA investigations

Root cause analysis

GMP manufacturing

Cross-functional collaboration

Cleanroom operations

Floor-based troubleshooting

Education

Bachelor's degree in Microbiology / related science

Tools

TrackWise

Veeva Vault

Kneat

Pharmasuite

PI Vision

MODA

Job description

Our pharmaceutical manufacturing client is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. This individual will serve as a technical resource on the manufacturing floor, providing guidance on aseptic processing, contamination control, environmental monitoring, sterility assurance, and cleanroom best practices. The role partners closely with Operations, Quality, Environmental Monitoring, Engineering, and Technical Services teams to support manufacturing activities, investigations, CAPAs, process improvements, and sterility assurance programs. The majority of time will be spent in GMP manufacturing areas supporting production activities, troubleshooting issues, coaching operators, and ensuring compliance with aseptic processing standards.

REQUIRED SKILLS AND EXPERIENCE

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 5+ years of experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
• Experience in sterile, aseptic, parenteral, or injectable product manufacturing environments.
• Strong understanding of contamination control, sterility assurance, environmental monitoring, and aseptic processing.
• Experience conducting manufacturing investigations, root cause analysis, deviations, and CAPA activities.
• Proven ability to provide hands‑on technical support within GMP manufacturing environments.
• Experience partnering cross‑functionally with Manufacturing, Quality, Engineering, and Operations teams.
• Ability to work within cleanroom environments and provide floor‑based manufacturing support.

NICE TO HAVE SKILLS AND EXPERIENCE

• Experience in TSMS, MSAT/MS&T, Sterility Assurance, Environmental Monitoring, or Technical Services functions.
• Background supporting aseptic filling, formulation, visual inspection, or sterile drug product manufacturing.
• Experience with smoke studies, airflow visualization, APS (aseptic process simulations), or EM programs.
• Familiarity with TrackWise, Veeva Vault, Kneat, Pharmasuite, MODA, PI Vision, or similar GMP systems.
• Experience training and mentoring operators or technicians on aseptic techniques.
• Prior support of 24/7 commercial pharmaceutical manufacturing operations.
• Experience analyzing environmental monitoring and microbiological data trends.