- Aequor (San Diego, CA)
- …participate in assessmentsCollaborate with IT teams, vendors, business users, and internal quality compliance staff to ensure that CSV activities are planned and ... Summary:Responsible for planning, writing, implementing and reviewing computer system validation ( CSV ) protocols of GxP computerized systems.Serve as the CSV … more
- Charles River Laboratories (Memphis, TN)
- …Data Integrity projects to identify and ensure the safeguarding of * data in compliance with site procedures, regulatory requirements, and corporate policies. ... staff specific to computerized system validation projects. Provide support for CSV staff, System Owners and System Administrators of computerized systems/laboratory… more
- Fujifilm (College Station, TX)
- …lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation ( CSV ) and Lifecycle procedures with Data Integrity requirements at ... **Position Overview** The Manager , CSV will be responsible for...regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. + Plan and… more
- Jabil (Hunt Valley, MD)
- …environmental impact and foster vibrant and diverse communities around the globe. SUMMARY: The CSV Manager will play a critical role in bridging the gap between ... This individual will be responsible for overseeing Computer System Validation ( CSV ) activities, ensuring compliance with regulatory requirements and internal… more
- J&J Family of Companies (Danvers, MA)
- …Learn more at https://www.jnj.com/medtech **We are searching for the best talent for a** Manager , Global Clinical Compliance . This is a remote role available in ... the continental USA. **Purpose:** The Manager , Global Clinical Compliance is responsible for...cross functional decisions and the potential downstream effects on data quality and integrity. + Provides mentoring/coaching and management… more
- Bristol Myers Squibb (Summit, NJ)
- …test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation, and post-execution review. ... + Coordinate recipe configuration, master data setup, and validation in Syncade MES. + 3+...QA, and IT to align on requirements and ensure CSV deliverables are compliant and audit ready. + Ensure… more
- Bristol Myers Squibb (Princeton, NJ)
- … Compliance /QA, Architecture, and Engineering; excellent communication skills. + Data -driven mindset with experience instrumenting and reporting product KPIs and ... **Summary:** We are seeking a highly skilled and motivated Medical Content IT Product Manager to support our Veeva Vault Medical platform. This role will be critical… more
- Bristol Myers Squibb (Indianapolis, IN)
- …matters, and defends their work before regulatory agencies and auditors. + Provides CSV expertise and guidance. + Responsible for compliance with local and ... to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT...Exec. Director, IT and be responsible to deliver on compliance and risk management for digital processes to achieve… more
- AeroVironment (Huntsville, AL)
- **Worker Type** Regular **Job Description** **Summary** The **Sr. Field Operations Manager ** plans, coordinates and conducts Small Unmanned Aircraft (SUAS), Tactical ... Vehicle (UGV) training, field demonstrations, and customer service visits ( CSV ) both domestic and internationally. **Position Responsibilities:** + Tracking of… more
- ThermoFisher Scientific (West Hills, CA)
- …helping find cures for cancer. **Discover Impactful Work:** The Senior Manager Manufacturing Engineering will lead strategy and performance of off-the-shelf ... and validation). + Drive improvements in efficiency, repeatability, and data integrity through automation upgrades or new installations. **Team Management**… more
- US Tech Solutions (Columbia, SC)
- …Expected work includes process development / automation, webservice calls, parsing various data formats (xml, csv , SOAP, HL7, etc.), and route development. ... deployment, and post implementation support. The focus will be on enhancing custom data management and transformation processes in the Rhapsody software, to set up… more
- West Pharmaceutical Services (Exton, PA)
- …to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation ( CSV ). + Actively engage with the ... **Job Summary** The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps,… more
- Amgen (Washington, DC)
- …processes from legacy systems to S/4HANA EAM with minimal disruption. Partner with business Data Manager to deliver data strategy. + Architect, configure, ... align with 21 CFR Part 11 computerized systems validation ( CSV ) and GxP regulatory frameworks. + Analyze current business... lake. + Lead data quality and data migration readiness efforts, ensuring compliance with… more
- Steampunk (Mclean, VA)
- …Rate limiting, and policies via Anypoint API Manager to protect sensitive data and ensure compliance . + Proficient in maintaining API versioning and ... to CloudHub, Hybrid, and On-Prem environments. + Experience processing and transforming various data formats (including XML, JSON, CSV , PDFs and flat files)… more
- GovCIO (San Antonio, TX)
- …aggregation. + Experience with JSON, REST APIs, and Elasticsearch Query DSL. + Familiarity with data formats such as JSON, XML, and CSV . + Knowledge of incident ... the incumbents will be responsible for integration of new data feeds into the Elastic stack and optimization of...role-based access control (RBAC), encryption, and auditing. + Ensure compliance with DoD security standards, including DISA STIGs and… more
- J&J Family of Companies (Raritan, NJ)
- …+ Excellent understanding of Global Regulatory Affairs systems, processes, and system/ data integrations with downstream systems for analytics, compliance , and ... for technical delivery in partnership with the Technical Product Manager . They play a dual role as both the...+ Ensure the integrations meet relevant security, privacy & compliance standards + Drive continuous improvement across the product… more
- Insight Global (Westlake, OH)
- …of Gentran: Server for Windows, ANSI x12 Standards, MuleSoft Anypoint Partner Manager , FTP, SFTP. Confluence, Jira, SAP IDOCs and Oracle Database knowledge a ... ecosystem: Gentran, MuleSoft, SAP, Oracle. * Maintain Disaster Recovery protocols, compliance , and testing support. * Conversant in the following X12 Specification:… more
