- Fujifilm (Durham, NC)
- …The role will serve as the system owner for FDB's electronic validation lifecycle management system. The Vice President of Commissioning, Qualification and Ops ... with Engineering, Quality Assurance, and Operations teams to integrate validation processes into project workflows, ensuring seamless execution and compliance.… more
- Fujifilm (Holly Springs, NC)
- …System modifications through the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems + Collaborates and ... the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing… more
- Fujifilm (Holly Springs, NC)
- …in an FDA regulated facility. * High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems , automation, ... team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy… more
- CBRE (Charlotte, NC)
- …Consultative skills * Ability to prioritize * Interprets and manages risk using systems that demonstrate appropriate control and validation of risk mitigation ... a "license-to-operate" expectation and must be supported by effective management control systems . Procedures need to be established, maintained, and tested to ensure… more
- Amgen (Holly Springs, NC)
- …support functions providing coaching, guidance and direction in regards to deviations, quality systems and compliance aspects. The initial focus of this role will be ... and nights. + Oversee ANC startup activities for facilities, utilities, equipment, systems and processes with alignment and integration into the Amgen Quality … more
- Insight Global (Browns Summit, NC)
- …project and initiative for change management, process control & improvement, validation reporting, and program process improvements to support and add additional ... responsibilities will be broken down 60% controls and 40% validation to include writing documentation for risks, installation ...Bradley) * Prior P&G experience * Familiarity with P&G Systems and Software * CPG bottling or jarring experience… more
- VTI Life Sciences (Raleigh, NC)
- …(preferred but not required). They must have previous Engineering and/or Validation experience. The candidate will have some business development responsibilities ... Relevant, professional experience, ideally within Life Sciences industry, specifically Validation , Commissioning and Qualification within the Pharmaceutical, Biologic, Biotechnology… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …release processes, ensuring seamless integration with SAP S/4HANA and other related systems (QMS, LIMS etc.,) and driving business process excellence in a regulated ... This role involves strategic oversight and technical expertise in SAP systems , working closely with cross-functional teams to enhance manufacturing processes,… more
- Amgen (Holly Springs, NC)
- …at the Amgen North Carolina site. + Provide system ownership for process systems and equipment supporting operations at the site. + Provide engineering support for ... construction, startup, commissioning and qualification of new or modified systems . + Identify, support, and/or lead implementation of engineering-based improvements… more
- Lilly (Concord, NC)
- …will apply the newest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact to our environment. ... and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges.… more