- Twist BioScience (South San Francisco, CA)
- …quality standards. Oversee and execute comprehensive computer system validation ( CSV ) activities, including IQ, OQ, PQ protocols and documentation, specifically ... from a software integration perspective.Expertise in computer system validation ( CSV ) and GxP documentation practices, particularly for custom-built systems.Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations (eg, Part 11), laws (eg, GDPR), and DS standards (eg, SDLC, CSV ).Drive continuous improvement by applying expertise in GAMP5, Good Practices Guides, and ... or Senior Management level - Required 7+ years of strong expertise in GxP regulations, CSV , 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep… more
- Cytiva (Miami, FL)
- …validation (PV), cleaning validation (CV) and Computer Software Validation ( CSV ) protocols and/or Plans and Reports.Assist and approve deviation investigations, ... corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation activities.Be the subject matter expert for Change Control on launched products, managing the local Change Management Board.Improve and develop… more
- JobScanner (Mooresville, IN)
- …Additional Preferences Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, Strong documentation skills and attention to detail, ... with experience in generating validation deliverables and training materials. Proficiency in English (written and spoken). Indianapolis [ US, PR sites] Occasional off-hours and weekend work expected. 10-15% domestic/international travel required. [ Local… more
- JobScanner (Clarks Hill, IN)
- …preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation ( CSV ) principles (eg, GAMP 5, 21 CFR Part 11, Annex 11). Experience ... authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials. Ability to work cross-functionally and… more
- Infosys (Austin, TX)
- …and propose improvements. Experience in REST SOAP XML JSON, Flat Files ( CSV , Fixed-Width). Experience in integration of RPA solutions with existing IT ... infrastructure, applications, and databases, by designing APIs, data interfaces, and connectivity solutions to facilitate smooth data exchange between systems. Experience in object-oriented programming languages such as Java and C++. Experience in XML, XML… more
- Avela (San Francisco, CA)
- …Responsibilities include the following: Export data from the Avela system to Excel CSV format Copy and paste data into Google Sheets Filter data exports Upload ... CSVs to Avela system and take actions as needed Proactively communicate in writing your daily progress and quickly raise inconsistencies or issues to Avela Client Services Team This work is to be completed independently, no earlier than 2 pm PT and no later… more
- Ascential Technologies (San Diego, CA)
- …a regulated GxP environment. Direct, demonstrable experience with computer system validation ( CSV ) activities compliant with FDA 21 CFR Part 11, including developing ... validation documentation (protocols, reports) and managing the validation lifecycle for electronic systems. Experience managing complex data migration projects during system implementation. Experience in developing User Requirement Specifications (URS) and… more
- Joyce University (Draper, UT)
- …Immunization & CPR requirements. Entry Level - understanding file extensions (PDF, CSV , jpeg, DOCX, etc.) Other duties as assigned Requirements WHAT YOU BRING ... TO THE TABLE: Preferred education: Bachelors degree Preferred experience: 2-3 Years in Academic Setting EQUAL EMPLOYMENT OPPORUTNITY POLICY: Joyce University provides equal employment opportunities to all employees and applicants for employment and prohibits… more
- BioSpace (Tarrytown, NY)
- …practical experience of IT Risk Management Methodology to Computer Systems Validation ( CSV ) and Computer Systems Assurance (CSA) models. Establish the framework to ... ensure non GxP systems adhere to documentation standards and manage the evaluation of tools to support system testing. Oversee the budget and resources, ensuring efficient and effective use of resources. Oversee IT quality incident investigations, including… more
- AHRC Nassau (Glen Head, NY)
- …limited to approvals (Pay batches & exceeding hours). Reconcile pay batch and CSV file totals for accuracy. Payroll: Maintain communication with the Payroll Manager ... regarding any immediate payroll related issues or concerns. Assist with ensuring all documentation for leave of absence, PFL, and suspended employees is received and processed for accurate payment. Process and review biweekly electronic records, allocation of… more
- Bristol-Myers Squibb Company (Bothell, WA)
- …to the end of IQ/OQ/PQ and SR) and computer system validation ( CSV ) documents through system retirement. Excellent project and program management, communication ... skills, and technical writing skills are required. Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired. Possess the professionalism and technical… more
- BioSpace (Indianapolis, IN)
- …manufacturing operations. Lead and support delivery strategies, quality assessments, and CSV and C&Q verification plans. Collaborate with site automation leadership ... to integrate resources into the project team. Assist with site hiring and capability building. Collaborate with other corporate engineering groups and Lilly IT to develop delivery strategies and execution plans. Manage project delivery metrics and… more
- iMPact Business Group (Fort Lauderdale, FL)
- …including test method validation (TMV) and computer system validation ( CSV ). Collaborating with cross-functional teams including quality, manufacturing, and R&D. ... Maintaining compliance with regulatory standards and internal documentation protocols. Analyzing process data and reporting findings to support process improvements. Participating in troubleshooting efforts to resolve production or test issues during NPI.… more
- PACIV (San Juan, PR)
- …the Life Sciences sector, is looking for a Computerized System Validation ( CSV ) Specialist/Engineer IT Systems , for its Puerto Rico office. Job Description: ... The Computerized System Validation ( CSV ) Specialist/Engineer will be responsible for development and execution of Computerized System Validation ( CSV )… more
- Cognizant (Muskegon, MI)
- Sr/Lead CSV Specialist Cognizant Technology Solutions in LSMG is seeking for a Sr/Lead CSV Specialist who could join our team of Engineering professionals in a ... hear from you! **Job Location:** **Muskegon, MI (Onsite)** **Role Responsibilities:** The CSV Lead manages quality control checks on engineering project work. The … more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** CSV Engineer **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless ... Engineer will be responsible for ensuring all Computerized Systems Validation ( CSV ) lifecycle activities meet Sanofi's quality requirements and fulfil regulatory… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an integral part of the Curia ... Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer will provide guidance and expertise on...provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the… more
- Lilly (Indianapolis, IN)
- …to enable the making of medicine "with safety first and quality always". The CSV Lead will provide technical leadership across the different site and global IT ... contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with… more
- Lilly (Indianapolis, IN)
- …and purchasing equipment; authoring Equipment Qualification (EQ) and Computer System Validation ( CSV ) packages, managing the EQ and CSV processes, and providing ... **Responsibilities:** + Responsible for design and execution of laboratory CSV initiatives, System Administrator duties, system upgrades, and data integrity.… more
