- 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 (Harmans, 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 (Indianapolis, IN)
- …people around the world. **Responsibilities** Drug Product External Manufacturing (DPEM) Sterility Assurance /Micro Secondary Loop Subject Matter Expert provides ... This role provides guidance to primary loop with respect to daily micro and sterility assurance activities and provides oversight of these activities in support… more
- Lilly (Indianapolis, IN)
- …for Ph3 and commercial launches. **Responsibilities:** The Sr. Manager of TS/MS Sterility Assurance is responsible for leading/mentoring a technical staff in ... support of the site sterility assurance strategy...process support, EMPQ, Sterilization Validation, Aseptic Process Simulations, and contamination control. Key deliverables and objectives include: Team and… 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
- Actalent (Fort Dodge, IA)
- …Associate, you will play a crucial role in leading and contributing to the sterility assurance and contamination control team. You will collaborate with ... production and other teams to ensure that analytical processes meet sterility assurance standards aligned with GMP and regulatory expectations. Your focus will… more
- Bristol Myers Squibb (Indianapolis, IN)
- …gas testing, and cleanroom qualification. + Strong knowledge of microbiological techniques, sterility assurance , and contamination control. + Thorough ... sterility and endotoxin testing, growth promotion, microorganism identification, contamination control, etc. + Supervise environmental monitoring activities, including… more
- Sanofi Group (Waltham, MA)
- …vaccines and commercial) is a distinct advantage. + Thorough understanding of contamination control and sterility assurance regulatory requirements and ... **Job Title:** Lead GMU Technical Operations **Location:** Framing, MA, Waltham,...partnership with operational unis and across all responsible sites ** Lead with innovation** **:** + Enhance partnership with operational… 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