- BioAgilytix (Durham, NC)
- …users on the use of automated systems. Serve as subject matter expert ( SME ) for select laboratory systems in a GxP environment.Authors Standard ... an Automation Expert , ensuring the efficient operation of automated laboratory equipment , conducting maintenance, troubleshooting, and repairs as necessary,… more
- Insmed Incorporated (Bridgewater, NJ)
- …function. These responsibilities include running the day-to-day operations of the laboratory including equipment qualification and maintenance. The Manager will ... New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager, Laboratory operations will manage the internal analytical laboratory...as well as the design and setup of new lab expansions.Serves as the analytical development SME … more
- Lundbeck (Bothell, WA)
- …review SOPs, development reports, and technical reports In partnership with QC, serve as the Subject Matter Expert ( SME ) in the transfer of analytical ... transfers, qualifications and validations and ultimately serving in a Subject Matter Expert role. Key...and Process Development (PD) groups Oversee routine maintenance of laboratory equipment and the critical reagent program… more
- Merck & Co. (Rahway, NJ)
- …including prefilled syringes, auto-injectors, on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and combination ... inhalers, auto injectors, pen injectors, on-body infusers/injectors, etc Eagerness to identify lab capability gaps, drive procurement of new equipment , and… more
- Catalent (St. Petersburg, FL)
- …on existing clients/products that have opportunities for improvement. Is expected to become the Subject Matter Expert for the client products, processes and ... projects and Product Development Projects; c) Stability Protocols and cleaning validation documents; d) Deviations, Laboratory Investigations and other ad… more
- United Therapeutics (Silver Spring, MD)
- … validation activities, serve as the validation subject matter expert in specific areas of equipment validation and may serve as the primary ... diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently… more
- Bristol Myers Squibb (Devens, MA)
- …for capital project teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to ... Validation Engineer I supports the successful implementation of manufacturing and laboratory equipment at multi-use sites through interaction with internal… more
- System One (Summit, NJ)
- …adhering to a change management process. + Supports the execution of equipment qualifications and validation protocols. + Supervises vendors for qualification ... and preventive maintenance of equipment . + Supports equipment qualification and validation activities. + Develops...maintained in compliance. + May be called upon as SME in both internal and regulatory audits. Requirements +… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …risk assessments and process parameter classification + Provide hands-on review and subject matter expertise of Validation lifecycle documentation including ... manner, and in support of corporate objectives + Act as the quality / validation SME for Change Controls supporting GMP/GLP systems. + Ensure required Standard… more
- Novo Nordisk (Clayton, NC)
- …Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs) + Serve as the Subject Matter Expert ( SME ) of the multiple quality ... Clayton Process Representative as assigned. Serve as a FP subject matter expert for QA...core validation areas (sterilization, packaging, cleaning, utilities, laboratory methods or equipment , process, or computer… more
- Novo Nordisk (Clayton, NC)
- …Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs) + Serve as the Subject Matter Expert ( SME ) of the multiple quality ... Clayton Process Representative as assigned. Serve as a FP subject matter expert for QA...core validation areas (sterilization, packaging, cleaning, utilities, laboratory methods or equipment , process, or computer… more
- Novo Nordisk (Clayton, NC)
- …standardized + Laboratory Equipment Validation & System support + Laboratory IT System support + Lead Lab Projects & Product Transfer Projects + ... demonstrate attention to detail preferred + Serve as a subject matter expert on QC...communication skills (verbal & written) required + Troubleshooting for laboratory equipment required + Validation … more
- Amgen (Holly Springs, NC)
- …directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role ... writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation...work order and PM system for laboratory equipment . + Assisting with review of validation … more
- Sartorius (Yauco, PR)
- …area objectives and requirements. Also, it will be responsible for the calibration and validation status of the lab equipment and instrumentation. Grow with ... quality, safety, discipline, GMP, GLP and housekeeping in the lab . + Supervise laboratory activities; establish responsibilities...for laboratory budget. + Responsible for the laboratory equipment and test methods validation… more
- General Motors (Warren, MI)
- …deliver high-quality results. Provide training in new and existing procedures. Hardware Subject Matter Expert . Supports all integration issues. Ensures ... knowledge and understanding of all aspects of the function, you will provide expert judgment and analysis for the design, development and implementation of technical… more
- BAE Systems (Herndon, VA)
- …ABC **Required Education, Experience, & Skills** We are seeking a highly skilled Video Engineer Subject Matter Expert ( SME ) to join our dynamic team. ... Develop technical specifications and documentation for video delivery systems. + Maintain a lab /test environment for new equipment and software before it touches… more
- Chenega Corporation (Frederick, MD)
- …all original data files; tabulate and analyze telemetry data and provide results to Telemetry Support Subject Matter Expert ( SME ) for review as needed. + ... technician shall execute scientific studies, analyze data, and maintain laboratory space and equipment . Our company offers...GLP animal studies; and assist in the maintenance and validation of telemetry equipment as needed. +… more
- Pfizer (Mcpherson, KS)
- …of packaging engineering / process trials and studies. Serve as subject matter expert for component equipment interfaces and capabilities ensuring that ... related disciplines. Participate on technical team for discrepancy and investigation resolution, equipment and process validation activities, SCARs, SCN and new… more
- Randstad US (Morton Grove, IL)
- …and Validation for OTC, pharmaceuticals and cosmetics. The position will be the Subject Matter Expert and be able to support the facility during ... Validation Program for all products and product contact equipment . + Leads the execution of the cleaning and...and follows-up on the implementation of corrective actions + Subject Matter Expert in the… more
- Lilly (Indianapolis, IN)
- …internal business customers. **Key Objectives/Deliverables:** DPEM Laboratory Secondary Loop Subject Matter Expert provides oversight, assistance, and ... the following: + Subject Matter Expert and Technical Mentor for Laboratory system...micro/sterility testing. + Strong Coaching/Mentoring skills. + Knowledge of laboratory quality system, method, and equipment . +… more
