- Merck (Durham, NC)
- …the EMEA / AP or US region. **Primary Responsibilities:** + Delivery of best-in-class computer systems validation to capital projects. + Drive the adoption ... colleagues and coordinate activities across sites. + Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC),… 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...responsible for the implementation, execution and assessment of quality systems , procedures, and records to support compliant GMP operations.… 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 ... NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of … more
- Lilly (Concord, NC)
- …similar is strongly preferred. **Additional Preferences** + Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, GAMP 5, 21 ... the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...needs. Working closely with global and site teams, MES System Engineer will ensure compliance with validation … more
- Novo Nordisk (Clayton, NC)
- …project deliverables preferred + Understanding of system development lifecycle including validation of computer systems , operation & maintenance & ... discussions in the DI and compliance space + Assess systems of various complexity for compliance gaps ( system...+ Minimum of four (4) years of experience in computer system validation or quality… more
- Cognizant (Raleigh, NC)
- … is a plus. . Strong understanding of GMPs, regulatory compliance, and computer system validation (CSV) principles. . Excellent communication skills, ... across teams. . Proficient in writing and reviewing protocols, specifications, and validation documents. . Experience with issue tracking systems and managing… more
- Lilly (Durham, NC)
- …with C&Q / Verification and Validation oversight including automation and computer systems validation . + Previous experience with capital project ... Demonstrated Leadership capability leading a team. + Proficiency with computer systems including Microsoft office products, Trackwise,...+ Previous use of KNEAT - or other electronic validation software. + Previous computer system… more
- Lenovo (Morrisville, NC)
- …**About Our Team** Lenovo's Cloud Service Provider Group (CSP) is seeking a ** System ** **Engineer** with server or GPU test/ validation and debug expertise. At ... Server System Engineer **General Information** Req # WD00080626 Career...experience * Bachelor's or higher in Electrical Engineering or Computer Engineering * Test/ validation and debug experience… more
- Lilly (Concord, NC)
- …security . Demonstrated ability to influence without authority . Solid knowledge of Computer System Validation process . Demonstrated ability to analyze, ... and equipment relying on applicants' business area knowledge and computer skills. Solves existing system problems, analyzes...issue escalations . Produce and maintain local project and validation documentation . Ensure systems remain in… more
- Lilly (Concord, NC)
- …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Proficiency with computer ... QRM principals and ensuring the integration of Global Quality System requirements into the design + Consult with Network...and visual inspection + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other… more