> Markdown version of [/jobs/ext/1109100-sterility-assurance-technician](https://www.wearedevelopers.com/jobs/ext/1109100-sterility-assurance-technician). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sterility Assurance Technician - **Company:** MEDASOURCE CO - **Location:** Durham, NC, United States - **Experience:** Expert - **Salary:** $58,240.0 - $62,400.0 - **Contract:** Temporary contract - **Skills:** Technical Data Management Systems, Trackwise - **Published:** June 17, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=23c82f89d18febad ## About the Role Do you have experience in Sterile field situational awareness?, * Minimum 2+ years of experience supporting pharmaceutical cGMP manufacturing * Experience within 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: o Filling operations o Formulation activities o Isolator operations o 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 Preferred Qualifications * Environmental Monitoring (EM) experience * Microbiology background * Bioburden control experience * Equipment qualification experience * Validation experience * Smoke study experience * Deviation investigation support * CAPA and change control experience * Experience with quality systems such as: o TrackWise o Kneat o Other QMS platforms Candidates should be comfortable: * 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 Schedule Requirements* Night shift: 6:00 PM - 6:00 AM * 2-2-3 rotating schedule * Must be flexible to support: o Production needs, * How many years of experience do you have in supporting pharmaceutical cGMP manufacturing? * Do you have experience in aseptic processing? * you have in supporting pharmaceutical cGMP manufacturing? Ideal Answer: Minimum: 2 How many years of experience do you have in filling, formulation, and or/isolator operations? ## Description 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 environment. Key Responsibilities * 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 ## Related Videos - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) - [Why you shouldn’t build a microservice architecture ](https://www.wearedevelopers.com/videos/261-why-you-shouldn-t-build-a-microservice-architecture) - [Security Pitfalls for Software Engineers](https://www.wearedevelopers.com/videos/726-security-pitfalls-for-software-engineers) - [I broke the production](https://www.wearedevelopers.com/videos/484-i-broke-the-production) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Building software that scales with Typescript](https://www.wearedevelopers.com/videos/415-building-software-that-scales-with-typescript) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [System change: restart as developer?](https://www.wearedevelopers.com/magazine/39-system-change-restart-as-developer) - [A Guide to Green Tech and Green IT Careers](https://www.wearedevelopers.com/magazine/374-a-guide-to-green-tech-and-green-it-careers) - [How to Write a CV and Interview if You Don't Fully Qualify For The Job](https://www.wearedevelopers.com/magazine/183-how-to-write-a-cv-and-interview-if-you-don-t-fully-qualify-for-the-job) - [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated)