- Fresenius Medical Center (Lawrence, MA)
- …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... individuals with disabilities to perform the essential functions. . Extended computer -based work in an office environment. **EDUCATION** . Bachelor's Degree required… more
- Catalent Pharma Solutions (Chelsea, MA)
- …manufacturing. The candidate provides support in automation engineering, design, and validation . The Automation Engineer II contributes to the design and ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- Sumitomo Pharma (Boston, MA)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Bristol Myers Squibb (Devens, MA)
- …records. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... strong magnets. **Preferred Qualifications:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
- Bristol Myers Squibb (Devens, MA)
- …compliance + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... and verbally communicate in English + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. **Basic… more
- Bristol Myers Squibb (Devens, MA)
- …framework + Must have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Strong Project Management skills, and ... & Experience** : + Bachelor's or Master's degree in computer science, Bioinformatics, Computational chemistry/Biology, or experience in related field… more
- Charles River Laboratories (Wilmington, MA)
- …ensure that all requirements are properly tested. * May lead testing and validation efforts. * Work with customer personnel to identify required changes and ... * Education: Bachelor's degree (BA /BS) or equivalent in Computer Science or related discipline. * Experience: Minimum 5...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… 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
- Sumitomo Pharma (Boston, MA)
- …policies, processes, and systems to enable accurate and timely data capture, validation , and reporting + Oversee and directly manage the collection, integration, and ... + Strong knowledge of regulations and guidance related to FDA , OIG, CMS, FTC, and PhRMA + Strong knowledge...communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America… more
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