- Cardinal Health (Raleigh, NC)
- …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
- Actalent (Greenville, NC)
- …to be available for urgent off-hours inquiries. Responsibilities + Govern validation activities for equipment, processes, computer software, and cleaning ... Job Title: Quality Assurance Validation Engineer Job Description We are seeking an...Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP) is highly desirable. Additional Skills & Qualifications… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also… more
- GRAIL (Durham, NC)
- …control software). + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA ... power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's… more
- United Therapeutics (Research Triangle Park, NC)
- …and technical writing skills + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... manufacturing operations + A broad knowledge and practical experience of computer , equipment, and application validation (GAMP methodology), cGMPs, and… more
- Medtronic (Charlotte, NC)
- …exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty claim submissions and ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Astellas Pharma (Sanford, NC)
- …the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and ... includes yet is not limited to; equipment testing, SOP/batch record generation, validation protocol execution support, as well as cross site tech transfer… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... best practices + Review and approve laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols,… more
- Mentor Technical Group (NC)
- …our Talent Bank. + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory ... comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science...+ Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... + Maintain a clean and safe work-space + Maintain laboratory notebook and/or computer files (ie LIMS) according to standard, accepted practices + Participate in… more