Sterility Assurance Technician

Location: Research Triangle Park (RTP), NC

Schedule: Night Shift: 12-hour night shift, 2-2-3 rotation (6:00 PM – 6:00 AM)

Contract Duration: 6 months

Start Date: ASAP

Pay Rate: $28–30/hr

Work Environment: Onsite – Parenteral Manufacturing Facility

We are seeking a Sr. Process Technician – Sterility Assurance TS/MS to support aseptic manufacturing operations within a pharmaceutical parenteral manufacturing environment. This individual will serve as an extension of the Sterility Assurance team on the manufacturing floor, partnering closely with Operations, Quality, and Environmental Monitoring teams to ensure aseptic practices, contamination control, and bioburden control standards are maintained throughout production activities.

This is a highly floor-facing role that requires strong aseptic processing knowledge, hands-on cleanroom experience, and the ability to coach and guide manufacturing operators on proper GMP and aseptic behaviors. The ideal candidate will have direct experience supporting filling, formulation, isolator operations, and aseptic interventions in a classified manufacturing.

• Serve as a Sterility Assurance resource within aseptic manufacturing operations
• Provide real-time support on the manufacturing floor during production activities
• Coach, mentor, and reinforce proper aseptic behaviors with manufacturing operators
• Perform routine audits of aseptic practices, cleanroom behaviors, and GMP compliance
• Identify risks to aseptic conditions and support remediation activities
• Partner with Operations and Environmental Monitoring teams to maintain contamination control standards
• Support filling, formulation, isolator operations, and aseptic interventions
• Assist with troubleshooting and responding to unplanned manufacturing events
• Support deviation investigations related to sterility assurance, contamination control, and aseptic processes
• Participate in root cause analysis and corrective/preventative actions (CAPAs)
• Conduct procedural compliance reviews and identify improvement opportunities
• Support environmental monitoring and microbiological control initiatives
• Assist with qualification and validation activities related to sterility assurance
• Support smoke studies and other aseptic qualification activities
• Review and maintain GMP documentation in alignment with regulatory expectations
• Analyze manufacturing data and provide recommendations for compliant solutions
• Act as a technical resource for sterility assurance questions and concerns

• Minimum 2+ years of experience supporting pharmaceutical cGMP manufacturing
• Experience with in parenteral drug product manufacturing
• Strong understanding of aseptic processing principles
• Hands-on experience working in classified cleanroom manufacturing environments
• Experience supporting one or more of the following:
  • Filling operations
  • Formulation activities
  • Isolator operations
  • Aseptic manufacturing processes
• Knowledge of GMP documentation practices and regulatory compliance
• Experience identifying and correcting aseptic behaviors or compliance concerns
• Ability to work directly with manufacturing operators and cross-functional teams
• Comfortable being highly visible on the production floor
• Strong communication skills with the ability to coach and influence others

• Bioburden control experience
• Smoke study experience
• CAPA and change control experience
• Experience with quality systems such as:
  • Track Wise
  • Kneat
  • Other QMS platforms

• Working in cleanroom environments
• Coaching operators on GMP behaviors
• Addressing non-compliance professionally
• Supporting active manufacturing operations
• Collaborating with Operations, Quality, Validation, and Environmental Monitoring teams