- 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
- Curia (Rensselaer, NY)
- … validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation ) + Expert in cGMP documentation practices Physical ... Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist, assists with the validation activities throughout the… more
- Curia (Albany, NY)
- …and team members to keep apprised of computerized system needs, impacts on computer validation , project validation status, and other relevant issues ... CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and… more
- Actalent (Colonie, NY)
- …Good Practice (GxP) guidelines (eg, GMP, GCP as applicable). Hands-on experience with Computer System Validation (CSV) practices in alignment with GAMP5 or ... Skills + Education & Certification: Bachelor's degree in Information Systems, Computer Science, Engineering or a related field. PMP certification or similar… more
- Parexel (Albany, NY)
- …acquisition and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications ... with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded… more
- Actalent (Colonie, NY)
- …with FDA regulations (21 CFR Part 11) and GxP guidelines. + Oversee or coordinate Computer System Validation (CSV) efforts for new and updated systems. + Develop ... requirements and general data integrity principles (ALCOA+). + Experience with Computer System Validation (CSV) processes and GAMP 5 guidelines. + Proficiency in… more
- Cardinal Health (Albany, NY)
- …will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical requirements… more
- Jabil (Elmira, NY)
- …equipment associated with product launches. + Coordinate and support equipment and process validation lifecycle elements such as computer system validation , ... safety risk assessment, installation qualification, process risk assessment, operation qualification and performance qualification. + Author equipment and process standard operating procedures. + Author test protocols and technical report documents. + Perform… more
- Independent Health (Buffalo, NY)
- …internal and external solutions supporting Reliance Rx initiatives. The Data Validation Analyst develops standard operating procedures (SOPs) for existing and new ... for completeness, accuracy, and adherence to business requirements. The Data Validation Analyst is responsible for performing quality verification tasks and ensuring… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …reliably deliver benefits for patients worldwide. Position Summary Reporting to the Validation Senior Manager, the Validation Engineer (Manager, Validation ) ... and Manufacturing Organization (CDMO) by ensuring robust and compliant validation of equipment, utilities, and facilities across multiple client programs.… more