- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews and aids in developing… more
- Curia (Rensselaer, NY)
- …(5) years' relevant experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP quality control ... Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an integral part of the… more
- Kedrion Biopharma (Melville, NY)
- …of the CSV guidelines and procedures. **ESSENTIAL JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR ... systems + Develop CFR Part 11-compliant computer and automation systems Validation Plans, Qualifications Protocols (IQ/OQ/PQ), User Requirements, Traceability… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple ... + Proficient in using Microsoft Office applications (Word, Excel, Outlook) and validation database systems . + Ability to work collaboratively with… more
- Stantec (Albany, NY)
- …stored in GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The ... commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify that they are designed, installed,… more
- Regeneron Pharmaceuticals (Troy, NY)
- …include the following: + Develop and maintain an industry leading approach to computer systems validation . + Lead the development of processes and systems ... that drive compliance to critical regulatory requirements specific to IT systems , including enterprise systems . + Responsible for leading and maintaining a… more
- GE Aerospace (Niskayuna, NY)
- …rotating machinery + Experience leading multidisciplinary teams to mature complex engineering systems from concept through validation + Experience with product ... As a Senior Engineer in the Mechanical Components and Systems Lab, you will play a key role in...of rotating components, data acquisition, data reduction, and design validation . Proficiency using ADRE and LMS data acquisition and… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …compliance. * Applying practical experience of IT Risk Management Methodology to Computer Systems Validation (CSV) and Computer Systems Assurance (CSA) ... SOX, and other compliance requirements, across all our IT systems and processes. * Ensure policies, procedures, and practices...models. * Establish the framework to ensure non GxP systems adhere to documentation standards and manage the evaluation… more
- Ford Motor Company (Albany, NY)
- …test procedures You'll have * 5+ years of experience in vehicle-level software validation , systems integration, or embedded development * Strong proficiency with ... and post-merge software builds across multiple domains (chassis controls, body systems , thermal, etc.) * Drive end-to-end development fleet readiness including… more
- MTA (New York, NY)
- …specification of Decision Support systems and analysis Development of cross systems data validation and cleansing procedures Development of mapping tables ... design, implementation and continued maintenance and management, of Metro North's EAM systems . This position will provide expertise in the set-up and configuration… more
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