Sterility Assurance Scientist – Night Shift

United Pharma Technologies Inc; North Carolina; Sur place; USD 51 000 - 73 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) retirement plan

Paid time off

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP experience

Aseptic processing

Environmental monitoring

Contamination control

CAPA investigations

Deviation investigations

Night shift

Formation

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

Outils

Veeva Vault Quality

TrackWise

Kneat

MODA

PI Vision

Description du poste

Job Title: Sterility Assurance Scientist - Night Shift

Duration: 12+ Months

Company: United pharma Technologies

Schedule: 40 hours/week, rotating 12-hour shifts (2-2-3 schedule); initial training on day shift

Industry: Pharmaceutical / Biopharmaceutical

Job Summary

We are seeking two experienced Sterility Assurance Scientists to support aseptic parenteral manufacturing operations in a GMP-regulated environment. Candidates must have strong hands-on manufacturing floor experience, aseptic processing knowledge, and expertise in contamination control and sterility assurance.

Key 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.

Required 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.

Preferred Qualifications

• 5+ years of relevant industry experience.
• Experience with aseptic filling, APS/media fills, EMPQs, smoke studies, and isolator systems.
• Familiarity with Veeva Vault Quality, TrackWise, Kneat, MODA, or PI Vision.

Pay Rate:$45/hr on W2

Employees hired into this position are eligible for the following benefits, subject to 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 is provided other than that required by applicable state and local laws.