- Kelly Services (Anasco, PR)
- …and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes.. + Hands-on experience with EU MDR or MDD ... procedures, and remediation projects. + Experience in Ethylene oxide sterilization validation and requalification; Bacterial endotoxin test method validation and… more
- Fresenius Medical Center (Lawrence, MA)
- …programs as well as manufacturing sites as biocompatibility, sterilization and microbiology subject matter expert ( SME ) in accordance with all ... Industry Standards development and revision. + Provide support as subject matter expert during quality...contract sterilization facilities, test laboratories and external subject matter experts. + Other duties as… more
- Imperative Care (Campbell, CA)
- …- The Principal Quality Engineer - Biocompatibility & Sterilization is the subject matter expert who establishes processes, protocols, methods, and ... Title: Principal Quality Engineer - Biocompatibility & Sterilization This position is based in our Campbell,...our medical device products. This role will involve leading sterilization and biocompatibility activities and/or overseeing the work of… more
- PCI Pharma Services (Philadelphia, PA)
- …stepwise reduction of bioburden. In charge of defining and maintaining the sterilization processing categories and the product families. SME supporting change ... pioneer and shape the future of PCI. Job Title: ** Sterilization ** **Manager - Validation, Sterility Assurance, and Utilities/Facilities** Department/Group: Quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below. ... * Bioburden test method validation and monitoring * Radiation sterilization validation and dose audit management * Ethylene oxide...and CAPA support as a microbiology and sterility assurance subject matter expert . + Support… more
- Integra LifeSciences (Princeton, NJ)
- …one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below. ... * Bioburden test method validation and monitoring * Radiation sterilization validation and dose audit management * Ethylene oxide...and CAPA support as a microbiology and sterility assurance subject matter expert . * Support… more
- Veterans Affairs, Veterans Health Administration (Muskogee, OK)
- …all staff and develop competency forms for the device. The Advanced MST is considered the subject matter expert in the areas of assignment. He/She will be ... the manufacturer's instructions for set-up, pre-cleaning, manual cleaning, disinfection, sterilization and storage. The Advanced MST will review and...a month to stay current with procedures. As the subject matter expert , the Advanced… more
- LSI Solutions (Victor, NY)
- …goods health risk assessments. + Maintain sterilization validations, and act as sterilization subject matter expert for new product development. ... Act as a team lead for Quality Engineers or subject matter expert in a...documenting and reviewing risk assessments. + Experience in terminal sterilization . + Experience in cleanroom environmental monitoring. + A… more
- Fujifilm (College Station, TX)
- …activity records, according to cGMP regulations. + Lead deviation resolution and closure with subject matter expert and quality teams. + Responsible for ... scale up activities as necessary. + Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes.… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …+ Sterilization validation + Materials validation + Process validation + Provide technical subject matter expert ( SME ) support to change controls, ... Validation and system experience in the following applicable areas: + Sterilization and aseptic processing validation. + Cleaning validation of manufacturing… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …in parenteral processes. Experience + Subject matter expert in parenteral operations: aseptic processing, sterilization , sterile filtration, isolator ... new products and key lifecycle parenteral products. This position is the principle subject matter expert and process owner for the end to end manufacturing… more
- BEAT LLC (San Antonio, TX)
- …systems. Inspect, install, repair, prepare for disposition, and provide SPM of MDE. + Serves as the Subject Matter Expert ( SME ) for MDE in three (3) or ... levels of qualifications shall be applied to this position. CP shall provide expert -level experience in the repair, calibrate, and maintenance of all types of… more
- Fujifilm (College Station, TX)
- …Track Option:** + Successfully leads two or more projects at a time. + Perform as the Subject Matter Expert ( SME ) on a variety of projects and range ... + Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization , and inoculation **_Essential Functions Include:_** + Write and review… more
- Fortive Corporation (Irvine, CA)
- …guidelines, this position: + Requires broad technical knowledge of capital equipment. + Acts as a subject matter expert ( SME ) for the reliability of ASP ... Reliability Engineer will be responsible for the reliability testing of Terminal Sterilization and High Level Disinfection equipment designed by ASP. This position… more
- Envista Holdings Corporation (Yorba Linda, CA)
- …trends and implementing corrective actions. + Act as a Cleanliness and Contamination Control Subject Matter Expert ( SME ) during routine operations and ... know-how:** + ISO 13485 (Quality Management System for Medical Devices) + Sterilization (ISO 11137-1&2) + Analytical Methods (ISO 11737-1,2,3) + Clean room &… more
- Veterans Affairs, Veterans Health Administration (Chillicothe, OH)
- …assembly, sterilization and building case carts. The Lead will serve as the subject matter expert to guide staff through the proper procedures. ... relating to the continuous through SPS from decontamination through sterilization area to include proper preparation of instruments and...for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use… more
- UCHealth (Denver, CO)
- …the ability to perform routine testing of necessary equipment. Acts as a resource or subject matter expert for associate and mid level team members. ... items and instruments, inspection and packaging, identification of appropriate sterilization methods with appropriate cycle selection of sterilization … more
- Integra LifeSciences (Columbia, MD)
- …one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below. ... monitoring + Bioburden test method validation and monitoring + Radiation sterilization validation and dose audit management **SUPERVISION RECEIVED** Under direct… more
- Integra LifeSciences (Cordova, TN)
- …one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below. ... monitoring * Bioburden test method validation and monitoring * Radiation sterilization validation and dose audit management **SUPERVISION RECEIVED** Under direct… more
- Intermountain Health (Provo, UT)
- …Processing Association) + One year of work experience in Central Processing + Proficient and subject matter expert in all specialties + Able to train in ... correctly use CP equipment. + Perform and record all biological and chemical sterilization tests. + Issue and receive durable, moveable clinical equipment. + Issue… more