- Merck & Co. (Lower Gwynedd, PA)
- …Quality Assurance. Serve as an internal subject matter expert on scientific background and laboratory aspects of bioanalytical development. Holistically, ... be responsible to contribute with limited supervision to all hands-on laboratory aspects of bioanalytical assay development, qualification/ validation , technology… more
- BioAgilytix (Durham, NC)
- …and neckLight to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment , laboratory supplies, and laptop computer with a ... Ability to use a variety of computer software Previous GMP/QC Lab experiences preferred Working EnvironmentPrimarily GMP regulated laboratory environmentRare… more
- CGI Technologies and Solutions, Inc. (Plymouth Meeting, PA)
- ** Lab Equipment Validation SME ** **Category:** Testing/Quality Assurance **Main location:** United States, Pennsylvania, Plymouth Meeting **Position ... ID:** J1024-0244 **Employment Type:** Full Time **Position Description:** The Lab Equipment Validation SME will specifically be a member of the CGI Life… 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
- Astellas Pharma (Westborough, MA)
- …+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert , audit hosting / support, etc. + ... Validation Specialist will ensure that all critical GMP equipment and systems are validated and maintained in compliance...qualification packages and create supplemental protocols as necessary. + SME for validation software, such as Ellab… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …high levels of noise in production areas. Exposure to electrical office and laboratory equipment . Personal protective equipment required such as protective ... * Actively manages and completes all phases of assigned equipment , facilities, utilities and process qualification and validation...data related to the project as well as coordinate validation activities. SME in high complexity /… more
- Bristol Myers Squibb (Bothell, WA)
- …and qualification plans to support GMP operations. + Acts as a validation Subject Matter Expert ( SME ) providing support to multi-function teams, ... in GMP, a thorough understanding of lab /manufacturing equipment , and a proven track record in validation...inspections and audits, serving as the subject matter expert for validation processes.… more
- Takeda Pharmaceuticals (Social Circle, GA)
- … + Materials validation + Process validation + Provide technical subject matter expert ( SME ) support to change controls, investigations, ... Sterilization and aseptic processing validation . + Cleaning validation of manufacturing equipment . + Process and...may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves… 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
- Fujifilm (Research Triangle Park, NC)
- …other systems as needed. + Act as a subject matter expert for the development of engineering and validation documents, ie, User Requirement ... technology and equipment life cycle monitoring. Under minimal supervision, the Laboratory Engineer II is responsible for the day to day operational, maintenance,… more
- PCI Pharma Services (Rockford, IL)
- …future growth plans and expansion of analytical laboratory services. + Serve as a Subject Matter Expert ( SME ) on analytical laboratory processes, ... which include (but are not limited to): Temperature Monitoring of various Laboratory equipment , sampling and processing of Environmental Monitoring Samples,… more
- AbbVie (North Chicago, IL)
- …opportunities and cost reductions into policy, procedures, and good practices. + Develop into Subject Matter Expert in Abbvie's Paperless CQV initiative and ... members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment , facilities, utilities, product,… more
- AbbVie (Waco, TX)
- …and maintenance procedures/requirements to all government and corporate regulations. Act as a subject matter expert for all customer and regulatory ... inspections for laboratory validation , calibration and maintenance program deliverables. + Manages internal...of activities in support of commissioning or maintenance/calibration of laboratory equipment . + Investigates equipment … more
- Medtronic (North Haven, CT)
- …program initiatives and compliant with company best practices. They are a subject matter expert in mechatronics, equipment , equipment design, and ... and New Product Line Start-up, including Assembly and Test Equipment validation and qualification, associated with the...generate real solutions for real people. From the R&D lab , to the factory floor, to the conference room,… more
- Lilly (Durham, NC)
- …well as supporting internal and external audits as a laboratory IT system subject matter expert . **Key Objectives/Deliverables:** + Performs or supports ... IT systems and will be responsible for mentoring laboratory personnel on the use of electronic lab...Laboratory with the validation of laboratory equipment and… more
- Boehringer Ingelheim (Fremont, CA)
- …Group representative on simple or routine equipment qualifications. Serves as QC subject matter expert ( SME ) representing the department during ... Experience troubleshooting technical problems and/or equipment . + Subject matter expert in performing...OOS and CAPAs and change controls). Serves as QC subject matter expert ( SME… more
- Sutter Health (San Francisco, CA)
- …Med Center Van Ness **Position Overview:** $5,000 Sign-On-Bonus Functions as the technical and clinical subject matter expert in one or more areas of the ... level of safety and reliability in testing. **Job Description** : **JOB ACCOUNTABILITIES:** TECHNICAL SUBJECT MATTER EXPERT . * Functions as the technical and… more
- Verista (Hopewell, NJ)
- …+ Author appropriate Change Controls and Test Scripts and serve as Manufacturing's + Subject Matter Expert for applicable changes + Recommend and integrate ... systems, and validation practices + Expertise in scientific / technical subject areas - Equipment Qualification, Computer System Validation , Cleaning… more
- Randstad US (Fort Worth, TX)
- …for SOPs related to testing programs, laboratory operations and/or equipment operation, for validation projects, activities related to instrument ... calibration and maintenance; serve as instrument advocate. + Identify appropriate lab instrumentation purchases; perform qualification/ validation . + Conduct peer… more
