- Actalent (Winston Salem, NC)
- …, systems engineering. + Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance, audit, lab equipment, IQ, OQ, PQ. ... Validation Engineer Job Description This validation ...practices. + Ensure continued GxP compliance of QC laboratory computer systems and software. + Perform additional duties and… more
- Astellas Pharma (Sanford, NC)
- …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required Qualifications**… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation . + Assures compliance with SOPs upon ... our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and… more
- ThermoFisher Scientific (Greenville, NC)
- …off-hours questions.** **Key Responsibilities:** + Quality Validation : Govern validation activities for equipment, processes, computer software, and cleaning ... to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong...Associate's degree is minimally required; A Bachelor's degree in Computer Science, Engineering, or a related field, or an… more
- J&J Family of Companies (Wilson, NC)
- …Wilson, North Carolina. We are responsible for Process, Thermal & Cleaning Validation , Standardization of Equipment for New Product Introduction, and Life Cycle ... for an MSAT Engineer- Thermal to join our MSAT Validation team ; located in Wilson, NC! **Position Summary:**...knowledge and application of industry regulations including those of FDA , HPRA, EMEA and other authorities. + Excellent verbal… 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …can be audited and reviewed at appropriate intervals + Oversee the selection, validation , and implementation of software used for the generation of cGMP data + ... issued from time to time + Oversee the selection, validation , and implementation of software used for the generation...to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance KNOWLEDGE, SKILLS AND ABILITIES: Education:… 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
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Execute processes to ensure systems and/or solution achieve and maintain validation and/or qualification in accordance with regulations and guidance from the… more
- Sumitomo Pharma (Raleigh, NC)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more