Senior Scientist

Insight Global; Concord (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Insight Global is seeking a Sterility Assurance Scientist (Night Shift) to support sterile/parenteral manufacturing operations. This role will provide hands-on guidance on aseptic processing, contamination control, and environmental monitoring while partnering with Operations, Quality, Environmental Monitoring, Engineering, and Technical Services on investigations, CAPAs, and process improvements.

The position requires deep GMP knowledge, experience in cleanrooms, and the ability to support 24/7

Qualifications

• Bachelor's degree in a scientific discipline as listed.
• 5+ years in pharmaceutical/biopharmaceutical manufacturing support.
• Experience in sterile/aseptic product manufacturing environments.
• Strong contamination control, sterility assurance, and environmental monitoring knowledge.
• Experience leading investigations, deviations, and CAPA activities.
• Hands-on GMP floor support and cross-functional collaboration.

Responsibilities

• Serve as on-the-floor technical resource for aseptic processing and sterility assurance.
• Support environmental monitoring, contamination control, and cleanroom best practices.
• Collaborate with Operations, Quality, Engineering, and Technical Services on investigations and CAPAs.
• Troubleshoot manufacturing issues and coach operators in aseptic techniques.

Skills

Sterility Assurance

Environmental Monitoring

Aseptic Processing

CAPA & Investigations

Root Cause Analysis

GMP Compliance

Cross-functional Collaboration

Floor-based Technical Support

Education

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

Tools

TrackWise

Veeva Vault

Kneat

Pharmasuite

MODA

PI Vision

Job description

• -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 & 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.

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.