- Bristol Myers Squibb (Warren, NJ)
- …client relationships. **Specific Knowledge, Skills, Abilities:** + Knowledge of cGMP, GXP , GAMP, SDLC regulations, including 21CFR part 11, computer systems ... validation requirements and good documentation practices. + Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support cell therapy clinical manufacturing. + Ability to develop, delegate and motivate others including… more
- J&J Family of Companies (Titusville, NJ)
- …projects. + Familiarity with master data requirements in regulated industries (eg GxP ). + Knowledge of Agile project management methodologies or certification in PMP ... (Project Management Professional). Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,… more
- J&J Family of Companies (Raritan, NJ)
- …Supply Chain and SAP ERP integration. Ensure various compliance requirements, including GxP , SOX, and Privacy, and their applicability in the application integration ... area. **Requirements:** Employer will accept a Bachelor's degree in Information Technology, Computer Science, Electronics and Instrumentation, Electrical Engineering or related field and 5 years of experience in the job offered or in a Sr Manager MuleSoft… more
- System One (Princeton, NJ)
- …expertise in C# .NET development, Medidata Rave integration, and experience working in GxP /Part 11 compliant environments. The engineer will play a key role in ... designing and maintaining data integrations between Medidata Rave, LIMS, and reporting systems, supporting critical clinical data workflows. Key Responsibilities: + Develop and maintain APIs using REST services or newer technologies. + Collaborate with the… more
- Integra LifeSciences (Princeton, NJ)
- …Digital project implementation from project planning to go live. + Knowledge of GxP , GAMP5, 21CFR Part11 and industry best practices. + Thorough understanding of the ... principles of computer systems validation, SDLC methodologies and testing best practices. + Strong written and verbal communication skills ensuring the ability to interact with the business, peers and vendors in a professional manner. + Ability to work well… more
- Cytel (Trenton, NJ)
- …or functional requirements. + Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. Here at Cytel we want our employees to succeed and we ... enable this success through consistent training, development and support. To be successful in this position you will have: + Bachelor's degree in Life Sciences, Health Informatics, or related field + 10+ years of progressive experience in clinical data… more
- System One (Princeton, NJ)
- …progress and business metrics. + Ensure compliance with CFR Part 11/ GxP regulations including documentation, validation, and audit readiness. + Modernize legacy ... Systems: CTMS, Medidata RAVE, IWRS/IVRS + Compliance: CFR Part 11, GxP , validation/documentation systems Ideal Leadership Qualities + Strategic and grounded -… more
- J&J Family of Companies (Titusville, NJ)
- …Experience in Pharmaceuticals/Healthcare industry and good Knowledge of SOX & GxP compliance regulations. + Exposure to Advanced Therapies and Clinical distribution ... processes + Experience with Agile methodology and Software Development Lifecycle Management model and documentation. **Leadership Skills & Behaviors** + Learning agility, flexible, thriving on change and able to adapt to it + Focuses on Business agility, Agile… more
- J&J Family of Companies (Titusville, NJ)
- …lifecycle. + Experience launching digital products in regulated settings, including GxP compliance, collaboration with Technology Quality teams, and following SDLC ... processes. + Leadership capabilities and negotiation skills, as well as the ability to effectively assimilate and communicate complex information from multiple sources. + Skilled in identifying project issues, leading resolution efforts, and ensuring clear… more
- Actalent (Rahway, NJ)
- …Strong Windows OS management and troubleshooting skills. + Experience with GxP systems and documentation. + Networking troubleshooting skills and Ethernet ... problem-solving skills. Additional Skills & Qualifications + Experience with Acronis. + Experience with Service Now. + Experience with Tanium. + Experience with network label printers. Work Environment The work environment requires the ability to operate in… more