- Lilly (Concord, NC)
- …Science related field** **Previous CSQA / CSV experience** **Proficiency with GMP computer systems validation including regulations governing them** ... etc. and assure that validation artifacts follow Good Documentation Practices.** **Assure computer systems (including but not limited to IT systems , Lab… more
- J&J Family of Companies (Wilson, NC)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures ... + Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology. + Keeps systems… more
- CREO (Durham, NC)
- …gathering to implementation, validation , and post-implementation support. This includes Computer Systems Validation (CSV) and, importantly, applying ... + EU Annex 11 + GAMP 5 + SDLC and custom software development + Computer Systems Validation (CSV), Computer Software Assurance (CSA) and modern … more
- Lilly (Durham, NC)
- …work irregular hours, shifts, and weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical computer ... up as a member of the site IT organization. The Manufacturing Execution Systems (MES) Principal Engineer is responsible for the deployment of PharmaSuite MES on… more
- Lilly (Durham, NC)
- …temporarily work irregular hours, shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical ... member of the site IT organization. The Manufacturing Execution Systems (MES) Sr Principal Systems Engineer is...a culture of compliance aligned with internal and external computer system quality standards. + Comply with the organization's… more
- Lilly (Concord, NC)
- …experience with C&Q / Verification and Validation oversight including automation and computer systems validation + Use process knowledge and control ... understanding of the process and its associated equipment, facilities, computer systems and operations + Lead and...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… 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
- Lilly (Durham, NC)
- …employment position. **Preferred attributes but not required** : + Proficiency with GMP computer systems validation including regulations governing them + ... computer system program is established and compliant with LQS302 Computer Systems including IDS, Automation, and laboratory computer system lifecycle… more
- Actalent (Clayton, NC)
- …or more core validation areas (sterilization, cleaning, process or computer validation ) preferred. Experience in cGMP documentation practices & regulations ... Our client, an expanding biopharmaceutical company, is seeking a Validation Specialist to join their team. They will primarily be responsible for performing… 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
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