- Bristol Myers Squibb (Devens, MA)
- …. **Summary:** We are seeking a highly skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team at the Devens ... accordingly. + High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Bristol Myers Squibb (Devens, MA)
- …systems and manufacturing execution system recipes, computer systems , and laboratory instrumentation. + Implement validation philosophies and master ... regulatory inspection readiness. Work collaboratively with peers within the Validation Execution function, Manufacturing Systems , Information Technology,… more
- Cognizant (Boston, MA)
- …or life sciences domain, including 2+ years in a management role. + Expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA). ... Lead** , you will make an impact by leading validation and testing initiatives across life sciences systems...this role, you will:** + Develop and implement comprehensive validation and test strategies aligned with FDA ,… more
- Cognizant (Boston, MA)
- …guarantee seamless integration across platforms. + Coordinate Computer System Validation (CSV) activities to ensure alignment with FDA , EMA, MHRA, and ... , you will make an impact by driving the validation and testing strategy for Document Management Systems... validation and testing strategy for Document Management Systems (DMS) and ensuring compliance with global regulatory standards.… more
- Medtronic (Boston, MA)
- …connected, compassionate world. **A Day in the Life** The Senior Quality Systems Manager drives the evolution of Medtronic's product development processes to set ... insights are incorporated into early design phases. + Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts… 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
- Catalent Pharma Solutions (Chelsea, MA)
- …(GMP) standards + Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating ... new and existing control equipment + Trains users on control system functionality (Programmable Logic Controller, Computer /Control Networks, Control Computers… more
- Integra LifeSciences (Braintree, MA)
- …**RESPONSIBILITIES** + Responsible for supporting the maintenance of the document control system during 1st shift. + Day-to-day management of resources, planning to ... and deadlines + This role ensures compliance within the document management system , document storage, retention, and document reconciliation + Serve as a document… more
- Teleflex (Mansfield, MA)
- …experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems , strongly desired * Experience in ... and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and… more
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