- Cardinal Health (Augusta, ME)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- NTT DATA North America (Pittsburgh, PA)
- …workflows. Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation (CSV) and quality ... with PMO governance, documentation standards, and regulatory requirements (eg, FDA CSV). Drive continuous improvement by identifying opportunities to streamline… more
- 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
- Astellas Pharma (Westborough, MA)
- **Principal Computer System Validation Specialist** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every ... AIRM is headquartered in Massachusetts. Astellas is announcing a **Principal Computer System Validation Specialist** opportunity at their **Astellas Institute… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Computer System Validation Requisition ID: 71527 Date: Nov 1, 2025 Location: Exton, Pennsylvania, US Department: Laboratory Description: ... providing input, and leading the documentation for equipment that requires a computer system validation approach. You will collaborate with internal stakeholders… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Engineer, IT Computer System Validation , Cell Therapy Devens role will provide ... the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change… more
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance with ... strategic guidance, technical expertise, and hands-on support throughout the validation lifecycle, including planning, execution, documentation, and audit readiness.… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …than 110 countries and regions. **_Job Summary:_** Responsible for conducting validation studies in accordance with current industry standards and guidelines for ... the qualification and validation of manufacturing systems and supporting processes. **_Essential Job...+ Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to… more
- Zimmer Biomet (Austin, TX)
- …and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity. + Experience with penetration ... This role provides leadership and technical direction in software validation , verification, regression testing, and cybersecurity to ensure compliance with… more
- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more