- Bristol Myers Squibb (Devens, MA)
- …more: careers.bms.com/working-with-us . **Summary:** We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team ... system change controls, deviations, and CAPAs related to computer systems . + Provide training and guidance...current with industry trends and regulatory updates related to computer system validation . **Qualifications:** +… 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)
- …Regulatory requirements. + Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key Responsibilities**… more
- ThermoFisher Scientific (Cambridge, MA)
- …Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to ... Assurance oversight for PSG computerized systems for the entire system lifecycle from infrastructure qualification through application validation and… more
- Bristol Myers Squibb (Devens, MA)
- …+ Strong knowledge of regulatory requirements and industry standards related to computer system validation (CSV) requirements (eg, FDA , EMA, GAMP 5, 21 ... This role will primarily support the IT Compliance, IT Deviation Management, Computer System Audit, Change Management, Training Management, and the Risk… more
- Sanofi Group (Cambridge, MA)
- …processes adhere to the required validation protocols for FDA -compliant systems . Provide documentation and support for system validation , including ... mitigation strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between various systems… more
- Hologic (Marlborough, MA)
- …industry, or equivalent combination of education and experience + Knowledge of ISO 13485, FDA regulations, and cGMP is required. + Computer literacy is required. ... 2 is provided direction from Management to execute within Quality Systems processes. + Support Nonconforming Events investigation, disposition, and release activity.… more
- Philips (Cambridge, MA)
- …results. + Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by ... better management throughout the product lifecycle, as well as desired experience in Computer System Validation (CSV) and knowledge in 510K, PMA,… 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
- Astellas Pharma (Westborough, MA)
- …control systems . + Cross-functional Collaboration: Partner with Manufacturing, QC, Validation , Regulatory Affairs, and Supply Chain to align on QA expectations, ... compliance gaps and implementing corrective actions. Represent the QA function during FDA , EMA, and third-party inspections, and serve as a QA subject matter… more
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