- Sanofi Group (Pearl River, NY)
- **Job Title:** Sterility Assurance Lead - Contamination Control **Location:** Pearl River, NY **About the Job** We deliver 4.3 billion healthcare ... closely with the Head of Quality to ensure the effectiveness of the Contamination Control Strategy (CCS). + **Expertise in regulations** : Your knowledge of US… more
- Catalent Pharma Solutions (Hanover, MD)
- The ** Lead , Sterility Assurance ** will...compliance to regulations and standard in the subject of sterility assurance and contamination control. ... Systems on the Catalent MD sites. This position will lead the following areas: Aseptic processing in clean rooms,...Demonstrate strong scientific understanding of DP Sterility Assurance and ability to investigate contamination events.… more
- Lilly (Concord, NC)
- …to support communities through philanthropy and volunteerism. **Responsibilities:** The Principal Sterility Assurance Scientist is a technical role that assists ... in development and implementation of the site's sterility assurance programs and provides technical guidance...Disinfection; Gowning within GMP Classified Areas, Aseptic Processing Techniques, Contamination Control + Lead or assist in… more
- Lilly (Lebanon, IN)
- …at the manufacturing floor level + Provide technical guidance to the Process Team for sterility assurance programs + Lead or provide technical support for ... monitoring data + Lead or support risk assessments related to sterility assurance programs + Create, execute, review, and/or approve technical documents… more
- Lilly (Indianapolis, IN)
- …Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews. + Lead Investigate or provide ... for regulatory submissions. + Lead training courses related to sterility assurance programs. **Minimum Requirements:** + Bachelors Degree in Microbiology,… more
- Lilly (Indianapolis, IN)
- …Associate Consultant Scientist positions in the Technical Services / Manufacturing Sciences - Sterility Assurance Technology (TS / MS - SAT) group are positions ... control of the site's manufacturing facilities. The group develop and implement sterility assurance related initiatives, and provide technical leadership with… more
- Integra LifeSciences (Princeton, NJ)
- …the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. **ESSENTIAL DUTIES ... Collaboration:** + Collaborate closely with cross-functional teams (eg, quality assurance , regulatory affairs, R&D, production) to ensure contamination … more
- Fujifilm (College Station, TX)
- …leverage your expertise to guide our efforts in maintaining a contamination -free environment, support our product pipeline, and ensure regulatory compliance. ... College Station, TX **Primary Responsibilities:** + **Microbial Testing Oversight** : Lead and manage all aspects of microbiological testing, including sterility… more
- Integra LifeSciences (Princeton, NJ)
- …the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. **ESSENTIAL DUTIES ... player with advanced process engineering knowledge and a propensity to lead successful teams. An understanding medical device sterilization processes, validation,… more
- Imperative Care (Campbell, CA)
- …preferred) and understands applicable ISO and guidance documents related to sterility assurance -Sterilization (ISO11135) , Microbiology (ISO 11737 series and ... activities, process modification studies and failure investigations regarding microbiological contamination control, impact to product and validated sterilization cycles.… more