- J&J Family of Companies (Raritan, NJ)
- …We are searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to join our Team **!** Janssen ... Engineer - CSV is responsible for performing and managing Validation activities, with a focus on computer ...for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 Code of Federal Regulations… more
- Bristol Myers Squibb (Warren, NJ)
- …respond to business owners' requests regarding equipment qualification, standalone computer systems validation , and equipment and systems decommissioning ... cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation...discipline. + Minimum of 5 years of experience in FDA -regulated industry ( validation preferred), or 3 years… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of manufacturing ... the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions, this individual… more
- Sanofi Group (Morristown, NJ)
- … computer science) or previous experience in Pharmacovigilance Safety Database/ validation experience working in a highly regulated environment + Additional ... into the appropriate technical language to ensure that configuration, operations, validation , and/or analytic reporting deliverables meet business needs. This role… 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 ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills....Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up… 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
- Lilly (Branchburg, NJ)
- …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. ... local and corporate policies). + Provide IDS technical and/or validation direction related to computer system Change...regulations (eg cGMP's, 21 CFR Part 11, Computers Systems FDA ) and other applicable regulations (eg Privacy, OSHA, etc.)… 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 by Global ... Validation Plans/Reports. Ensure compliance with applicable regulations (eg, FDA 21 CFR Part 11, EU Annex 11, ICH...and Requirements Bachelors or Masters degree in Life Sciences, Computer Science, Engineering, or related field. Minimum 5 years… more
- Nestle (Bridgewater, NJ)
- …for supporting the Vowst and Microbiome Sciences team with systems upgrades, computer system validation activities, and system administrative activities. This ... in accordance with GxP, HIPAA, EU Annex 11, and FDA 21CFR Part 11 regulations. This role will also...LIMS, MES, ERP). * Collaborate with Information Technology (IT), Computer System Validation (CSV), and Quality Assurance… more
- Teva Pharmaceuticals (Edison, NJ)
- …and Equipment systems, with minimal supervision. + Develop and review Validation / Qualification protocols and reports that challenge the critical parameters ... related to installation, operation, and performance of related facility, utilities, computer systems, or equipment. + Analyze complex datasets to ensure adherence to… more