- 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 ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Kedrion Biopharma (Melville, NY)
- _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play a critical role in ensuring the compliance and reliability of ... environments. As a Subject Matter Expert (SME), you will lead validation efforts and support the development, commercialization, and lifecycle management of… more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer ... Collaborate across functional areas across the organization to maintain and improve computer system validation processes to ensure robust, efficient, and… more
- Insight Global (New York, NY)
- …validation SOPs, templates, and documentation tools for continuous improvement - Certified Computer System Validation Professional (CSV) null We are a company ... Job Description Insight Global is seeking an IT GxP Validation Lead for one of our clients in the... plans, risk assessments and defining testing strategies for computer systems used in GxP environments. You will develop,… more
- University of Rochester (Rochester, NY)
- …ClinPro LBL (TM) computerized clinical label generation system. + Provide input into validation protocols and implement computer system validation of ... Clinpro by acting as second QA check of the execution of validation scripts, and manages metrology activities; calibration of in-process packaging equipment and… more
- University of Rochester (Rochester, NY)
- …/distribution and documentation of all equipment as applicable. + Provide input into validation protocols and implement computer system validation of ... ClinPro by acting as second QA check of the execution of validation scripts, and manages metrology activities; calibration of in-process packaging equipment and… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …and execution of implementation requirements. + Assist with periodic reviews of computer system validation and instrument qualifications. + Assist with the ... + Assist with the creation of documentation for instrument qualification and computer software/hardware validation protocols and final reports in conjunction… more
- Cognizant (Albany, NY)
- …systems is a plus. . Strong understanding of GMPs, regulatory compliance, and computer system validation (CSV) principles. . Excellent communication skills, with ... ownership of full project lifecycle from design through commissioning and validation . . Deep expertise in DeltaV DCS, including architecture, configuration, and… more
- Cognizant (Albany, NY)
- …cloud, Portal studio Experience in C# and object-oriented programming concepts Author Computer System Validation (CSV) documents such as Functional Risk ... Validation Plan, System Test Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following the client… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and ... leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards. + Can act… more