- Medtronic (Danvers, MA)
- …of component manufacturing. This includes activities related to test method validation , process validation , inspection improvements, and process/quality change ... development experience in a regulated industry (medical device preferred) + Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems … more
- Cognizant (Boston, MA)
- …management and delivery with benefits delivered as committed required. + Experience in GxP systems , Computer System Validation , and consistent track ... responsible for: + Act as subject matter expert on system design and architecture. + Solutioning and designing new...record in the support of FDA regulated systems and business required. +… more
- Charles River Laboratories (Wilmington, MA)
- …analysis and requirements gathering for small, medium and large scale system implementations within regulated and/or non-regulated IT environments. Participate in ... * Deliver presentations to IT and business management. * Work with IT systems subject matter experts to develop solutions to support business needs. * Articulate… more
- Takeda Pharmaceuticals (Lexington, MA)
- …HCP engagement. Up to 50% remote work allowed. **REQUIREMENTS:** Bachelor's in a Computer Science, Information Systems , or data related field plus 5 years ... data, healthcare providers, etc.); Ensure seamless data integration between internal systems (CRM, ERP, financial systems ) and external healthcare/pharma… more
- Mentor Technical Group (Boston, MA)
- …Requirements/Knowledge/Education/Skills: Required: + Bachelor's degree in Data Science, Statistics, Computer Science, Information Systems , or a related field. ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Sumitomo Pharma (Boston, MA)
- …processes, and systems to enable accurate and timely data capture, validation , and reporting + Oversee and directly manage the collection, integration, and ... + Partner with internal and external partners/vendors to implement and/or enhance systems supporting transparency reporting + Serve as the subject matter expert on… more
- Bristol Myers Squibb (Devens, MA)
- …and framework + Must have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Strong Project Management skills, and ... understanding of drug development lifecycle and expertise in relevant IT systems . The successful candidate will translate business needs into effective technology… more
- Bristol Myers Squibb (Devens, MA)
- …compliance + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... tasks consistently with the safety policies, quality systems , and GMP requirements. + Completing training assignments to ensure the necessary technical skills and… more
- Bristol Myers Squibb (Devens, MA)
- …records. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... tasks in a manner consistent with the safety policies, quality systems , and GMP requirements. + Completing training assignments to ensure the necessary technical… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... + Performs tasks in a manner consistent with the safety policies, quality systems , and GMP requirements. + Completing training assignments to ensure the necessary… more