TSMS Sterility Assurance Scientist

TSMS Sterility Assurance Scientist – US, North Carolina – Initial 12-Month Contract – Life Sciences

Be part of a next-generation pharmaceutical project that’s transforming how medicines are made.

We’re supporting a major new-build facility in North Carolina, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for a TSMS Sterility Assurance to support this project and help deliver this world-class program.

What you’ll deliver:

• Serve as an embedded resource and extension of the Sterility Assurance Process Team, providing hands-on guidance to operators and manufacturing personnel during production and spending the majority of the shift coaching, auditing, and communicating within the aseptic processing areas.
• Monitor and reinforce best aseptic practices within classified areas; identify and report events affecting the maintenance of aseptic conditions in clean rooms; correct improper aseptic technique when observed and communicate corrected behaviors to supervisors.
• Troubleshoot process issues and respond to unplanned or unexpected events in classified areas, including events requiring aseptic interventions; lead and organize remediation activities (i.e. recovery cleaning, alarm response, etc.) from day-to-day unplanned events and shutdowns.
• Recognize when issues require escalation and engage the appropriate technical, quality, engineering, or leadership resources.
• Ensure a safe working environment through compliance with safety rules and active participation in safety-related activities.

What you’ll need:

• Bachelor’s degree in microbiology, Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or another relevant scientific or technical discipline.
• Demonstrated understanding and relevant experience of scientific principles required for manufacturing parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.
• Experience owning or providing sustained, hands-on technical support of a manufacturing process or product line through ongoing commercial or scale-up production.
• Direct experience troubleshooting manufacturing issues, investigating manufacturing deviations, performing root cause analysis, and supporting CAPA development and execution.
• Experience mentoring scientists, technicians, and/or manufacturing operators.

Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!