- VTI Life Sciences (New York, NY)
- …some of the biggest companies in the Life Sciences industry. We are currently seeking a CSV Engineer for a 2+ month contract to work on a Class 1 Medical Device ... Engineering is required. * 5+ years of Biopharmaceutical or Medical Device CSV experience is required. * Specific hands-on experience with validating BarTender… more
- Regeneron Pharmaceuticals (Troy, NY)
- …also plan, coordinate and participate in compliant computer system validation ( CSV ) process for systems which require formal validation documentation in accordance ... with regulatory and company manufacturing standards. In this role, a typical day may include the following: + Generates, executes and/or reviews master and completed computer system(s) qualification and validation protocols, summary reports and associated data… more
- Kedrion Biopharma (Melville, NY)
- …will lead management of validation lifecycle for computerized systems. The CSV specialist will contribute to the development, execution and continued optimization ... of the CSV guidelines and procedures. **ESSENTIAL JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11… more
- Cognizant (New York, NY)
- …different regulatory guidelines like 21 CFR part11, Annexure 11 and Fundamentals of CSV is mandatory. **Qualifications** + Minimum 3 to 4 LV LIMS V7+ Implementation ... experience in Agile Methodology + Expert level knowledge of LV Data Model and Entity Relationships + Expert level knowledge of LV Stability and advanced level knowledge of LV Pharma Solution + Expert level knowledge of LV Calculation Builder. Hands-on… more
- IBM (New York, NY)
- …disciplines: Data Warehousing, Web Services, ETL, SQL, Force.com FTP, and Batch CSV integrations, and data migrations. - Experience with other relevant technologies ... and integration patterns such as Salesforce and IQVIA. - Familiarity with healthcare-specific compliance and security requirements like GxP and HIPAA. - Experience with Agile methodologies. - Bachelor's degree in computer science, engineering, or a related… more
- NBC Universal (New York, NY)
- …Cloud Services. + Experience with metadata file types (.xml, .json, . csv ) & metadata schema creation/manipulation using JavaScript or other scripting languages. ... + An individual that knows their way around desktop hardware, software applications, MAC/PC OS and network connectivity. + Must have proficient experience with Microsoft Office applications (including Outlook, PowerPoint, Word, Excel). Desired Characteristics:… more
- NBC Universal (New York, NY)
- …(eg ACP-100) + Experience with both Jira and Confluence migrations (Jira CSV , Confluence Backup, and/or JCMA/CCMA) + Tableau certifications (eg Tableau Desktop ... Specialist) + Scrum master experience and/or working knowledge of how to deploy and manage Agile teams in Jira + Working knowledge of Smartsheet including granting user access and permissions + Experience with relational databases and SQL + Familiarity with… more
- Unither Pharmaceuticals (Rochester, NY)
- …Specifications. If completed by an external company, the computer systems validation ( CSV ) specialist will be responsible for obtaining these documents prior to ... developing the validation project plan and qualification protocols. Generates validation project plans detailing responsibilities along with the required actions to validate a system. Collaborating with the impacted departments to develop risk assessments… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for ... Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution. **Job… more
- NTT America, Inc. (NY)
- …on a pharmaceutical manufacturing shopfloor with an understanding of Computer Systems Validation ( CSV ) process + Experience working on L2 automation systems or on L3 ... manufacturing systems such as MES, LIMS, QMS, & ERP that support the batch process manufacturing of pharmaceuticals or biologics + Experience deploying IT systems that need to adhere to Good Manufacturing Practices (GMP) + 3+ years of prior working experience… more
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