- 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 Cell Therapy ... Engineer will be responsible for managing the computerized system validation (CSV) activities for major projects to comply with.... **Key Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens CTF. + Develop and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Bristol Myers Squibb (Devens, MA)
- …utility systems, process automation systems and manufacturing execution system recipes, computer systems, and laboratory instrumentation. + Implement validation ... to work and manage within a regulatory environment. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory… more
- Cognizant (Boston, MA)
- …and business teams. **In this role, you will:** + Develop and implement comprehensive validation and test strategies aligned with FDA , EMA, and GxP standards, ... 2+ years in a management role. + Expertise in Computer System Validation (CSV) and Computer...of ALM Test Management tools. + Deep understanding of FDA , EMA, GxP, and 21 CFR Part 11 requirements;… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms. + Coordinate Computer System Validation (CSV) activities to ensure alignment with FDA , EMA, MHRA, and ... **About the role** As a ** Validation & Testing Lead in Life Sciences** ,..., you will make an impact by driving the validation and testing strategy for Document Management Systems (DMS)… more
- Cognizant (Boston, MA)
- …an MES Validation Lead,** you will make an impact by driving Computer System Validation (CSV) initiatives within the Life Sciences domain, ensuring ... QA, IT, and business units. **In this role, you will:** * Lead validation strategy and execution for Document Management Systems and manufacturing platforms. *… more
- Philips (Cambridge, MA)
- …in information technology engineering or computer science. + Strong understanding of FDA validation , ITIL processes, and regulatory compliance. + You must be ... and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on key performance… more
- AbbVie (Worcester, MA)
- …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …role will also support clinical/biomarker assay development and validation . For more information on CMC, click here ... and leadership for Takeda clinical and biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality… more
- Integra LifeSciences (Boston, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more