- Cardinal Health (Boston, MA)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment ... + Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems . + Manage Computer System Validation (CSV) activities in alignment with global regulatory ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...standards ( FDA , EMA, MHRA). + Utilize ALM tools to streamline… more
- Sumitomo Pharma (Boston, MA)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- Bristol Myers Squibb (Devens, MA)
- …in biologics or cell therapy manufacturing. + Strong understanding of CSV ( computer system validation ), data integrity, and regulatory requirements ... adherence to GxP, FDA , and other applicable regulatory standards in system implementation, validation , and operations. + Partner with internal stakeholders… more
- Bristol Myers Squibb (Devens, MA)
- …Specific Knowledge, Skills, Abilities: + Strong working knowledge of Tech Transfer, Computer System Validation , and Commissioning and Qualification processes ... Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager, Quality Systems - Change Control and Quality Risk Management (QRM) Process… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …procedures in alignment with FDA and QSR standards. + Develop and execute validation plans for service test systems and methods. + AUTOMATION & WORKFLOW ... Required/Preferred Education and Experience + Bachelor's Degree Electrical Engineering, Computer Engineering, Mechanical Engineering, Systems Engineering, or… more
- Bristol Myers Squibb (Devens, MA)
- … system installations, configurations, administrative and support functions including system validation lifecycles and training. + Provide local ... and technical support. + Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the… more
- Oracle (Boston, MA)
- …teams to ensure development environments, CI/CD pipelines, and configuration management systems support regulatory traceability and validation . + Provide ... and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system … more
- AbbVie (Worcester, MA)
- …Operations, Quality, IT and Maintenance. + Manage and supports control system including standalone Manufacturing equipment, systems upgrades, data migrations ... Data Historian systems . + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP,...PI, Rockwell PLC are required. + Direct experience with system development and validation , including development of… more
- Insight Global (Westborough, MA)
- …others as applicable. The role ensures these tools align with regulatory requirements (eg, FDA , IEC 62304, ISO 13485) and supports system access via Single ... SSO (Azure AD, Okta), enforce secure authentication and access controls. * Compliance & Validation : Support tool validation per ISO 13485 and 21 CFR Part 11,… more