- 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
- 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 (Durham, NC)
- …temporarily work irregular hours, shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical ... ground up as a member of the site IT organization. The Manufacturing Execution Systems (MES) Systems Engineer is responsible for the deployment and continuous… more
- Lilly (Durham, NC)
- …with C&Q / Verification and Validation oversight including automation and computer systems validation . + Previous experience with capital project ... skills. + Demonstrated Leadership capability leading a team. + Proficiency with computer systems including Microsoft office products, Trackwise, etc. +… more
- Mentor Technical Group (NC)
- …environment is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in ... + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts… more
- Lilly (Concord, NC)
- …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Proficiency with computer ... formulation, filling, and visual inspection + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other electronic validation… more
- Reckitt (Wilson, NC)
- …Engineers, the Program Lead and the Technical team to provide Quality oversight of validation activity relating to computer systems , introduction of new ... + Quality contact for review and approvals of projects associated with computer systems and validation ; while ensuring electronic systems and… more
- Teleflex (Morrisville, NC)
- …controls for Application, ensuring adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a ... * Bachelor's degree in a technical field such as Computer Science or Information Systems (a combination of education and experience may be considered… more
- Actalent (Winston Salem, NC)
- …and documentation practices. + Ensure continued GxP compliance of QC laboratory computer systems and software. + Perform additional duties and projects ... by management. Essential Skills + Engineering, quality assurance, quality system, validation , systems engineering. + Understanding of full compliance for… 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