- BeOne Medicines (Pennington, NJ)
- …will serve as the technical expert and lead for Computer System Validation /Computer System Assurance, ( CSV /CSA) Data Integrity & IT Compliance for ... Job:** + Serve as the GTS Lead for Computer Systems Validation /Computer System Assurance and...Executes CSV /CSA deliverables for new and current Computerized Data Management systems . + Participates in… more
- Insight Global (Gaithersburg, MD)
- Job Description Insight Global is looking to hire a Computerized System Validation ( CSV ) SME to sit in a hybrid environment in Frederick or Gaithersburg, ... be responsible for technical authority and governance for the validation of GxP-impacting computerized systems ... Validation Strategy & Planning: Develop and maintain system -level and project-level CSV strategies aligned with… more
- AbbVie (North Chicago, IL)
- …+ Excellent technical writing, analytical, and problem-solving skills. + Experience with computerized system validation ( CSV ) and automation ... and Maintenance to support commissioning, start-up, and qualification activities. + Maintain validation status of systems through the execution of Periodic… more
- Insight Global (Gaithersburg, MD)
- …ensuring design compliance with AZ standards, GMP, GEP, SHE, data integrity (ALCOA+), and computerized systems validation ( CSV ) principles. - Technical ... management) - Strong knowledge of GMP, GEP, SHE, data integrity (ALCOA+), and computerized systems validation ( CSV ) - Proven ability to provide technical… more
- J&J Family of Companies (Raritan, NJ)
- …**Preferred:** + Experience with budget management and financial oversight. + Experience with Computerized Systems Validation ( CSV ), SDLC, Agile/Scrum ... the medical devices industry, including regulatory requirements and industry trends. + Validation experience across equipment, process, and systems . + Change… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation ( CSV ) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation ( CSV ) and Data Integrity Programs (DI),… more
- Curia (Albany, NY)
- … CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide ... platform + And more! Responsibilities Computer Systems Validation + Manage multiple site and global CSV...team members to keep apprised of computerized system needs, impacts on computer validation , project… more
- Lilly (Lebanon, IN)
- … Validation Plan. * Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: + ... System + QMS * Perform risk assessments for computerized systems and develop strategies to mitigate...strategies to mitigate identified risks * Develop and Execute validation protocols for computerized systems … more
- Bristol Myers Squibb (Summit, NJ)
- …the Qualification of equipment and full CSV for single and multi-user Computerized Systems . + Develops validation /qualification deliverables such as ... and support of manufacturing and laboratory equipment and local benchtop/standalone computerized systems at multi-use sites through interaction with internal… more
- Mentor Technical Group (NC)
- …for the development and execution of Computer System Validation ( CSV ) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as the ... systems validation requirements. + Must have experience in configuring computerized systems with complex vendor software systems , and windows… more
- Astellas Pharma (South San Francisco, CA)
- …team, the Validation Engineer plans and executes risk-based qualification and computerized systems validation activities in cell and gene therapy ... and Qualification Lifecycle** + Plan and execute risk-based CSV for research computerized systems ..., Computer Science, Life Sciences. + 8+ years of Computerized Systems Validation experience with… more
- PACIV (Indianapolis, IN)
- …action items for any deficiencies resulting from Periodic Reviews. + Update Computer System Validation ( CSV ) documentation which may include design ... arrangements. Job Responsibilities + Execute Periodic Reviews of all departmental computerized systems supporting Clinical Trials (ie Parts Washers, Autoclaves,… more
- Pfizer (Mcpherson, KS)
- …with auditors in areas related to sterility assurance equipment, capex qualifications, computerized systems , process or cleaning validations as assigned. + ... and resolution of issues related to sterility assurance equipment, capex qualifications, computerized systems , process or cleaning validations as assigned. +… more
- Lilly (Indianapolis, IN)
- …BS in IT, Engineering or related discipline and 3+ years' experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical ... electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems +...or manufacturing. + Knowledge of GMP regulatory requirements, computer system validation , execution and data integrity +… more
