- zobility (Allen Park, MI)
- Position Description: The Hardware in the Loop (HiL) Software Validation Engineer supports the SW product development and system integration processes by developing ... for automated execution, implementing tests using Hardware in the Loop equipment , documenting and reviewing execution reports, reporting incidents, and tracking… more
- Aequor (Thousand Oaks, CA)
- … Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and ... combination product / medical device quality systems verification Strong process equipment knowledge - cell culture, fermentation, purification, filling, and… more
- Novo Nordisk Inc. (Durham, NC)
- …Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & ... 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products...help us make what matters. The Position Support people, equipment and processes for our operations areas to meet… more
- Catalent (St. Petersburg, FL)
- …b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive ... specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment , utilities, and computer systems;… more
- Lundbeck (Bothell, WA)
- …and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team.The Lu-SBP team leads and supports ... Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global… more
- Arthrex (Ave Maria, FL)
- …Skills:Skills Required for Engineer Tech Associate - Packaging - Packaging Validation Specialty* Basic knowledge of package testing equipment preferred.* ... Arthrex, Inc. is a global medical device company and a leader in new...Assist with various aspects of the packaging engineering development process as assigned.* Assist engineers with the creation, modification,… more
- CHRISTUS Health (Alice, TX)
- …health information documentation best practices and their rationale across health care practices. Medical Equipment Describes experience with basic medical ... common equipment problems Educates patients about the appropriate use of home medical equipment Ensures that all equipment and related supplies are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing ... vendor management, issues, deviations, corrections and remediation efforts for facility, equipment , systems and processes in support of personalized cell therapy… more
- Merck & Co. (Rahway, NJ)
- …standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR, Medical Electrical Equipment - EN 60601, Medical Device Software Standard ... a laboratory settingExperience with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, tensile/compression… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … improvement and implementation of new manufacturing technologies. Ensure successful manufacturing process comparability and process validation runs by ... assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.… more
- CMJobPoster (Temecula, CA)
- …Manufacturing of medical devices is a MUST HAVE Equipment & process qualification Process validation activities Change orders Problem solving Cross ... for task approach direction as well as peer review of verification/ validation activities. Bachelor Science or Bachelor Engineering, Electrical, Software, or… more
- BioAgilytix (Durham, NC)
- …their expertise in molecular biology, further developing their skillset in the development and validation of PCR assays. If you are a person who is energized by ... then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesCompile/ process data (make power export)Prepare summary tablesPeer review raw dataOrder… more
- Ducommun Incorporated (Appleton, WI)
- …commitmentHardware, Software and Documentation package descriptionSpecification of tester validation criteria and required customer deliverables.The process ... circuit boards for Aerospace and Defense as well as Industrial and Medical Industries. Job Summary Development of test solutions: Typically assigned to develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …routine manufacturing and protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality ... position with responsibilities for providing quality oversight for the manufacturing process , equipment , and associated deviations and investigations within a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …troubleshooting to identify root cause and appropriate corrective actions for equipment system problems Provides input in the development & execution strategy ... for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor troubleshooting… more
- Arthrex (Ave Maria, FL)
- …execute protocols for sterilization processes (ie EO, Gamma, X-Ray etc.) and equipment validation and re-validations, along with reports and conclusions; Manage ... of FDA and ISO guidelines for the sterilization modalities of medical devices required.Manufacturing process knowledge preferred.Project management and… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- …testing activities. Performs various quality control tests on raw materials, in- process and final product using approved test methods, Standard Operating Procedures ... with current Good Manufacturing Practices (cGMPs). Monitors and evaluates systems, equipment , records and trends data. Review/revise documentation (ie SOPs). Works… more
- Russell Tobin & Associates (Cupertino, CA)
- …consumer electronics. You will work with cross-functional teams to develop test process , execute tests and analyze test results.Key Qualifications: 2+ years of ... with understanding BMU protections. Understanding of EE bench test equipment and use and appropriate application. (Oscilloscopes, meters, data-loggers, power… more
- Stihl Inc (Virginia Beach, VA)
- …maximum equipment uptime and availability with day-to-day troubleshooting along with process and equipment improvement projects to maximize the efficient use ... Company Benefits Include: Multiple bonus opportunities with potential annual merit increases Medical , Dental & Vision Insurance Onsite Health & Wellness Center for… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- Job SummaryPerforms QA review of testing records of raw materials, in- process and finished products, stability samples, and non-routine sample analyses per ... regulatory inspections or internal/external auditsPerform review of release, stability, validation , analytical quality control tests on raw materials, in-processing… more
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