- Insight Global (San Francisco, CA)
- …* Ensure computerized systems and software used in support of manufacturing, quality management, and other GxP activities are developed, validated and maintained in ... FDA, EU and other international regulations and ISO standards. * Support quality risk assessment activities (eg, system level risk assessment, functional risk… more
- Charles River Laboratories (Memphis, TN)
- …* Certification/License: Certifications like Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training desired. ... staff specific to computerized system validation projects. Provide support for CSV staff, System Owners and System Administrators of computerized systems/laboratory… more
- Charles River Laboratories (Memphis, TN)
- …above. * Certification/Licensure: Certifications like Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training can ... of validation projects, ensuring timely delivery, meeting specifications, and maintaining quality throughout. * Prepare clear and concise validation deliverables for… more
- Curia (Albany, NY)
- CSV Systems Engineer II/III in Albany, NY...power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management ... provide guidance and expertise on various global and site CSV projects to ensure that quality teams...Preferred + Experience in the pharmaceutical industry Pay Range: CSV Systems Engineer II: $73,000-$112,000 per year.… more
- Bristol Myers Squibb (Devens, MA)
- …) to join our team at the Devens Cell Therapy Facility (CTF). The Senior CSV Engineer will be responsible for managing the computerized system validation ( CSV ... development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects. + Provide CSV input to… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Computerized Systems Validation Engineer ( CSV ) Engineer **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare ... Engineer will be responsible for ensuring all Computerized Systems Validation ( CSV ) lifecycle activities meet Sanofi's quality requirements and fulfil… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr. IT Engineer 1, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation ( CSV ). This ... Systems + Assists with managing the allocation of contract CSV resources and monitors the quality of their deliverables to support local IT projects +… more
- Lilly (Lebanon, IN)
- …and standardization. * Provide periodic status updates to Project Management * Devise CSV and quality strategies for control systems in collaboration with Site ... better for people around the world. The Senior Principal Engineer - Automation Engineering will work as a member...site and/or for capital projects. This role will provide CSV support leading and executing CSV activities… more
- Bristol Myers Squibb (Summit, NJ)
- …at BMS with our Cell Therapy team. The **Lead Computer System Validation ( CSV ) Engineer ** supports the successful implementation of manufacturing and laboratory ... all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems. + Develops validation/qualification… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist, assists with the validation activities throughout the plant, ... to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues. This role serves as a source of expertise in… more
- Mentor Technical Group (PR)
- …initiates corrective action of problems and deficiencies to ensure product quality . Develops manufacturing processes that are applicable to statistical process ... Qualifications Requirements/Knowledge/Education/Skills: + BBA in Engineering + Knowledge in CSV + Problem Solving Knowledge (Yellow or Green Belt knowledge)… more
- Mentor Technical Group (Caguas, PR)
- …equipment. + Support maintenance and calibration functions to improve compliance and quality . + Provide expertise in troubleshooting and root cause investigations. + ... are a plus. + Strong understanding of regulatory requirements and quality standards. + Excellent analytical, problem-solving, and communication skills. + Ability… more
- Caris Life Sciences (Irving, TX)
- …Caris is where your impact begins.** **Position Summary** Senior Software Design Quality Assurance Engineer thinks "outside the box" in the implementation ... practices. Guides software development project teams as a Computer Systems Validation ( CSV ) and Computer Software Assurance (CSA) quality subject matter expert… more
- Harmac Medical Products (Buffalo, NY)
- …of Openings 1 Salary Range $80,000-$85,000 Description Job Summary The Software Quality Engineer ensures the compliance of computerized systems validation ( ... Software Validation Engineer About the Organization Harmac Medical Products, Inc,...leads, participates on, and/or monitors cross-functional teams related to CSV process/product improvement as required. + Develops quality… more
- J&J Family of Companies (Jacksonville, FL)
- …& Johnson, Vision Jacksonville, FL is recruiting for a Senior Software Validation Quality Engineer , Quality Operations, location in Jacksonville, FL. The ... Senior Software Quality Engineer is primarily responsible to manage...change request assessments ( 5%) + Develops and conducts SDLC/ CSV training for IT and Operations. (10%) + Review… more
- Genentech (Oceanside, CA)
- …periodic reviews, manage user access reviews, project documents as per GSP/ CSV requirements. + Work effectively with other quality /manufacturing stakeholders. ... Team. + Ensure adherence to cGMP, GSP 111, and CSV 6 requirements across all operations. + Develop, implement,...meet the defined timelines without extensions. + Manage IT quality topics such as change management process. + Manage/lead… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in ... Indianapolis. The Validation Engineer II will be responsible for the drafting and...spaces including but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas. + Work… more
- System One (Strongsville, OH)
- Position Title: Senior Big Data Engineer (Python/PySpark) Provide locations/flexible work by preference: 1. Pittsburgh PA - Two PNC Plaza OR Cleveland OH - ... NumPy and MatPlotLib. With experience working with file based systems(supporting csv /parquet/) + Extensive knowledge in understanding Data and creating Data… more
- US Tech Solutions (San Bruno, CA)
- …for a person based on a comprehensive view of the evidence. **Responsibilities:** ** Quality Assurance Champion:** 1. Act as a champion of Quality Assurance ... and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from… more
- Quality Consulting Group (Juncos, PR)
- QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and ... + Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as… more