- Hologic (Louisville, CO)
- …development to meet divisional strategies and goals. + **Team Management** : + Lead the BSH Design Assurance team, including managers and Design Assurance engineers. ... ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant. + Address technical and project-based… more
- Truist (King Of Prussia, PA)
- …are not mentioned below. Specific activities may change from time to time. 1. Lead the execution of technical model validation reviews completed by the Truist ... Review Team. Work will consist of: a. Performing full or targeted scope validation assessments. b. Reviewing validations to ensure TAS concurs with the conclusions… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to preclinical and clinical biomarker assay development and validation . For more information on CMC, click here ... leadership for Takeda preclinical and clinical biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global… more
- Noblis (Atlantic City, NJ)
- …Systems (VCSs), which includes development of requirements, procurement, verification, validation , testing, implementation and deployment. The VS&R Program Office ... FAA Security Engineer will provide hands-on cybersecurity support to the FAA Security Lead and Technical Team at the William J. Hughes Technical Center for Advanced… more
- ARCO (Raleigh, NC)
- …team based in Raleigh-Durham, NC. As a Project Scheduler, you'll take the lead in driving the development, implementation, and management of project timelines for ... projects, including phases such as mechanical completion, commissioning, and validation (when applicable). + Coordinate timelines with internal design-build teams… more
- Genentech (Oceanside, CA)
- …Configure, deploy, and maintain MES software (Emerson Syncade or Pharamsuite). + Lead MES upgrades, patch management, and change controls. + Troubleshoot MES ... and system redundancy for critical GMP applications. **Compliance & Validation ** + Ensure systems meet GxP and FDA 21...FDA 21 CFR Part 11 requirements. + Author/execute technical validation documents (URS, FRS, DS, IQ/OQ/PQ). + Support internal… more
- PCI Pharma Services (Philadelphia, PA)
- …methods + Provide technical leadership for new product launches + Lead continuous improvement activities Secondary Responsibilities + Specify, purchase, and ... Acceptance Tests). + Responsible for determining OQ parameters to start validation . + Approves validation protocols and MPI's. + Leads SAT/FAT for all assigned… more
- US Tech Solutions (Maple Grove, MN)
- …a design assurance (or development quality team), supporting process validation , equipment qualifications, manufacturing line support, risk management, product ... to meet or exceed internal and external requirements. + Lead in the implementation of manufacturing assurances, and process...BS 0 - 2 Years with MS + Process Validation & Equipment Qualification Experience + Manufacturing line support… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …establishing product specifications, stability programs, material qualification, method validation , method transfer, and process validation . **Responsibilities** ... laboratories for method development, transfer, and QC testing. + Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal… more
- RTX Corporation (Cedar Rapids, IA)
- …the requirements + Perform technical planning, system integration, verification and validation , cost and risk, and supportability and effectiveness analyses for ... learn:** + You will gain Systems Engineering Requirements, Integration, Validation and Verification skills. + You will be provided...our products. At Collins, the paths we pave together lead to limitless possibility. And the bonds we form… more