- J&J Family of Companies (Raritan, NJ)
- …Responsibilities:** + Provide preparation, generation and flawless execution of Computer System Validation for GMP Systems and Processes. + Collaborate ... searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to...managing Validation activities, with a focus on computer systems , software, as well as GMP… more
- Lilly (Branchburg, NJ)
- …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and ... local and corporate policies). + Provide IDS technical and/or validation direction related to computer system...pharmaceutical regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg… more
- Nestle (Bridgewater, NJ)
- …for supporting the Vowst and Microbiome Sciences team with systems upgrades, computer system validation activities, and system administrative ... LIMS, MES, ERP). * Collaborate with Information Technology (IT), Computer System Validation (CSV), and... (QAV) in maintaining integrity and control of designated computer systems . * Monitor system … more
- Insight Global (Basking Ridge, NJ)
- … Systems Compliance -Senior Analyst to enhance and verify the compliance and computer systems validation (CSV) capabilities across systems managed ... Matrix, and Validation Plans/Reports. Ensure compliance with applicable regulations (eg, FDA 21 CFR Part 11, EU Annex 11, ICH E6(R3)). Collaborate with… more
- Sanofi Group (Morristown, NJ)
- …database + Previous experience in computerized system methodology for implementation and validation of IT systems **Why Choose Us?** + Bring the miracles of ... of the safety database as well as the development, validation and maintenance of the system enhancements...users and GPE to define business requirements for the system or related sub systems . + Responsible… more
- System One (Park Ridge, NJ)
- …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
- Bristol Myers Squibb (Warren, NJ)
- …and promptly respond to business owners' requests regarding equipment qualification, standalone computer systems validation , and equipment and systems ... cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and...discipline. + Minimum of 5 years of experience in FDA -regulated industry ( validation preferred), or 3 years… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of ... to the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions,… more
- Sokol Materials & Services (Skillman, NJ)
- …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up...AND RESPONSIBILITIES * Develop and execute commissioning, qualification, and validation protocols for equipment, facility systems , and… more
- Sokol Materials & Services (Skillman, NJ)
- …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more