- Nanobiosym, Inc. (Cambridge, MA)
- …the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with details of ... root cause analysis. + Utilizes DOE/DRM/COS/Lean principles and statistical process control to develop creative, thorough and practical technical solutions. + This is a hands-on position in a growing organization and an opportunity which will grow rapidly +… more
- Integra LifeSciences (Mansfield, MA)
- …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... audit, and environmental monitoring programs as necessary + Creates and finalizes validation protocols and report ensuring they are clear, concise and compliant to… more
- Integra LifeSciences (Mansfield, MA)
- …+ Works in accordance with all requirements for manufacturing medical devices (eg FDA QSR, ISO 9000, ISO 13485). + Completes required documentation as required by ... times. + Partners with engineering team to ensure completion of expansion & validation activities in a timely manner, acting as subject matter expert where… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... interoperability. + Ensure data quality, accuracy, and integrity through robust validation and monitoring practices. + Manage data sources across categories such… more
- Integra LifeSciences (Braintree, MA)
- …issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of refrigerant usage and system ... controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical industry. + Experience with cold storage validation and temperature mapping. more
- J&J Family of Companies (Danvers, MA)
- …customers + Support activities related to system change implementations, such as validation testing, operation procedure updates and training in a global setting + ... work force, supervisor or manager + Experience with SAP and EWM + Experience in FDA regulated industry and familiarity with CFR 21 Part 11, GMP, SAS, and Sarbanes… more
- Fujifilm (Boston, MA)
- …continuing education. + Participates in Synapse PACS testing and feature validation when deemed appropriate by SSAT/Education management. + Participates on various ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Review and approve user requirements, design specifications, and verification/ validation plans + Maintain traceability between clinical needs and technical ... control processes and risk management methodologies + Thorough understanding of FDA , EMA, and international regulations for medical devices and combination products… more
- Cognizant (Boston, MA)
- …benefits delivered as committed required. + Experience in GxP systems, Computer System Validation , and consistent track record in the support of FDA regulated ... systems and business required. + Strong interpersonal skills required. Excellent communication, networking, and influencing skills including the ability to manage across all management and organizational levels required. + Ability to manage and drive multiple… more
- ThermoFisher Scientific (Boston, MA)
- …Expertise (SME) and to lead and participate in method development, validation /verification, transfer, and submission of the rapid safety methods, including qPCR ... effectively with internal and external functions Significant front room FDA /Inspectional experience on stability programs **Working Environment:** Below is listed… more