*Job Title:* Sterility Assurance Technician
*Location:* Raleigh, NC
*Job Type:* Long Term Contract

*Position Summary:*
The Technician - Sterility Assurance role provides continuous support of parenteral operations to enhance and improve the assurance of sterile product manufacture. The technician works closely with operations and environmental monitoring personnel during all aseptic production activities. This position is responsible for addressing any sterility or product quality-related questions that arise during manufacturing. The Technician will be expected to develop a high level of expertise in aseptic processing within the TS/MS group while supporting the RTP Parenteral Facility.

*Key Responsibilities:*
* *Aseptic Assurance & Monitoring:*
* Actively coach, audit, and communicate within the Aseptic Processing areas for the majority of the shift.
* Reinforce best aseptic practices and serve as an extension of Sterility Assurance within the classified areas.
* Identify and report on events related to the maintenance of aseptic conditions, ensuring sterility assurance during manufacturing operations.
* Promptly communicate with Operations regarding aseptic techniques and personnel behavior.
* Lead and organize remediation activities following unplanned events or shutdown activities.
* *Training & Mentoring:*
* Lead, coach, and mentor personnel on proper aseptic techniques and practices during manufacturing activities.
* Provide guidance during qualification activities, such as smoke studies, and ensure compliance with best aseptic practices.
* Correct aseptic techniques and communicate the proper behavior to supervisors as needed.
* *Problem Solving & Compliance:*
* Gather, organize, and analyze data to develop compliant solutions and alternative methods of proceeding in case of issues.
* Conduct periodic internal reviews or audits to ensure adherence to procedures.
* Provide technical support for non-routine investigations (e.g., deviations, complaints), including execution of required studies.
* *Qualification/Validation Support:*
* Assist in qualification/validation activities to support bioburden control for the facility or equipment.
* Support other routine responsibilities within the TS/MS group, as assigned by management.
* *Safety & Environment:*
* Ensure a safe working environment through strict compliance with safety rules and regulations.
* Actively participate in safety-related activities to improve the safety culture of the team.

*Minimum Requirements:*
* High school diploma or GED.
* A minimum of 2 years of pharmaceutical experience supporting cGMP manufacturing.
* Experience with parenteral drug product manufacturing.

*Additional Preferences:*
* Experience in aseptic processing, environmental monitoring, microbiology, equipment qualification, and validation.
* Ability to analyze data and develop solutions for process improvement and problem-solving.
* Strong written and verbal communication skills.
* Previous experience with deviation and change management systems, including Trackwise.
* Familiarity with Kneat for qualification/validation processes.
* Strong interpersonal skills and the ability to work effectively in team settings.
* Strong self-management abilities with the capacity to work independently.
* Ability to prioritize and manage multiple tasks simultaneously.
* Strong oral and written communication skills, effectively interacting with all levels of the organization.

Job Types: Full-time, Contract

Pay: $25.00 - $32.00 per hour

Expected hours: 40 per week

Schedule:
* 8 hour shift
* Monday to Friday



Application Question(s):
* Do you have previous experience within a Pharmaceutical Manufacturing environment?

Ability to Commute:
* Raleigh, NC 27602 (Required)

Work Location: In person