Night-Shift Sterility Assurance Scientist - GMP Operations

United Pharma Technologies Inc; North Carolina; On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

Paid time off

Job summary

United pharma Technologies is seeking two experienced Sterility Assurance Scientists to support aseptic parenteral manufacturing operations in a GMP-regulated environment on rotating 12-hour night shifts. Initial training on day shift will be provided.

Candidates should have hands-on manufacturing floor experience, strong aseptic processing knowledge, and expertise in contamination control, deviation investigations, and CAPA.

Qualifications

• Experience in GMP pharmaceutical or biopharmaceutical manufacturing, preferably parenteral operations.
• Strong knowledge of aseptic processing, microbiology, environmental monitoring, and contamination control.
• Hands-on manufacturing floor support and troubleshooting experience.
• Experience with deviation investigations, root cause analysis, and CAPA.
• Ability to work in classified cleanrooms and rotating 12-hour night shifts.
• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.

Responsibilities

• Provide on-floor sterility assurance support during aseptic manufacturing.
• Monitor gowning, aseptic techniques, and contamination control practices.
• Troubleshoot manufacturing issues and coach operators on proper aseptic behaviors.
• Lead deviation investigations, root cause analysis, and CAPA activities.
• Support environmental monitoring, smoke studies, EMPQs, APS/media fills, and bioburden qualifications.
• Support isolator glove integrity testing, cleaning, sanitization, and validation activities.
• Collaborate with Manufacturing, QA, Engineering, and Technical Services teams.

Skills

GMP experience

Aseptic processing

Environmental monitoring

Contamination control

CAPA investigations

Deviation investigations

Night shift

Education

Bachelor's degree in Microbiology/Biology/Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Veeva Vault Quality

TrackWise

Kneat

MODA

PI Vision

Job description

United pharma Technologies is seeking two experienced Sterility Assurance Scientists to support aseptic parenteral manufacturing operations in a GMP-regulated environment on rotating 12-hour night shifts. Initial training on day shift will be provided.

Candidates should have hands-on manufacturing floor experience, strong aseptic processing knowledge, and expertise in contamination control, deviation investigations, and CAPA.