Sr. Scientist - Sterility Assurance

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

Job summary

Insight Global is seeking a Sr. Scientist in Sterility Assurance to support sterile/parenteral manufacturing operations. You will guide aseptic processing, contamination control, environmental monitoring, and cleanroom best practices on the manufacturing floor.

The role collaborates with Operations, Quality, Environmental Monitoring, Engineering, and Technical Services to drive investigations, CAPAs, and process improvements while ensuring strict adherence to GMP sterilization standards.

Qualifications

• Bachelor degree in a relevant scientific discipline as listed in must-haves.
• 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.

Responsibilities

• Provide hands-on technical support on the manufacturing floor, focusing on aseptic processing and sterility assurance.
• Coach operators and ensure compliance with cleanroom and GMP standards.
• Lead investigations, deviations, and CAPA activities to drive quality improvements.
• Collaborate with Manufacturing, Quality, Environmental Monitoring, Engineering, and Technical Services teams to support manufacturing activities.

Skills

Sterility assurance

Aseptic processing

Environmental monitoring

CAPA investigations

Root cause analysis

Cross-functional collaboration

GMP manufacturing

On-floor troubleshooting

Education

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline

Job description

Our pharmaceutical manufacturing client is seeking a Sr. Scientist within Sterility Assurance 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.

Must Haves:

• 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.