- ManpowerGroup (Raleigh, NC)
- … within a regulated environment. + Greenfield project experience. + Familiarity with electronic validation systems (eg, KNEAT Gx). **What's in it for me?** + ... + Perform Risk-Based Analysis and validate various Part 11 Systems . + Select validation objectives and standards, prepare protocols, and draft validation… more
- Fujifilm (Holly Springs, NC)
- …and monitoring * Ensures integration of TT process with other Quality Systems (Deviation/CAPA, Change Control, Validation ) * Provides guidance and quality ... equipment, hygienic utilities, quality systems , automation, manufacturing & IT Systems , and/or validation methodologies * Understanding of Data Integrity,… more
- Merck (Durham, NC)
- …technical services support in the areas of equipment and automation systems , validation , deviation management and product franchise. Specific assignments ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… more
- Lilly (Concord, NC)
- …with C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control strategy to make ... of the process and its associated equipment, facilities, computer systems and operations + Lead and establish annual quality...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… more
- Lilly (Concord, NC)
- …C&Q / Verification and Validation oversight including automation and computer systems validation + Proficiency with computer systems including Microsoft ... formulation, filling, and visual inspection + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other electronic validation… more
- GE Vernova (Wilmington, NC)
- …reviews including interfacing with requirements management, independent verification and validation , and systems and software quality assurance organizations ... team responsible for Instrumentation, Control and Monitoring, DCS, and Electrical systems associated plant cross- disciplinary and cross- systems simulation.… more
- Highmark Health (Raleigh, NC)
- …and outcomes. The incumbent delivers data profiling, conducts testing and systems validation to troubleshoot data anomalies, monitors data management ... as assigned. **EDUCATION** **Required** + Bachelor's Degree in Computer Systems Analysis, Data Processing, Healthcare Informatics, Management Information Systems… more
- Fujifilm (Holly Springs, NC)
- …equipment, hygienic utilities, quality systems , automation, manufacturing & IT Systems , and/or validation methodologies * Understanding of GAMP5, Data ... knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software * Understanding of large-scale drug substance manufacturing processes… more
- Fujifilm (Holly Springs, NC)
- …equipment, hygienic utilities, quality systems , automation, manufacturing & IT Systems , and/or validation methodologies * Understanding of GAMP5, Data ... * Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software is a plus * Understanding of the following processes… more
- Actalent (Clayton, NC)
- Validation Specialist Job Description As a Validation Specialist, you will perform revalidation on equipment and processes according to approved timelines. You ... will support validation activities related... activities related to changes in existing and new systems , including formulation, sterilization, cleaning, filling, and inspection processes.… more