Job summary: 5+years of CQV experience focused on utilities, process equipment, and process validation. Strong documentation experience across CQV lifecycle deliverables including URS/FRS, risk assessments, protocols, summary repor...
Summary : This role ensures that Client' IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing process...
Job Summary : The Plant Utilities Commissioning & Qualification (C&Q) Lead is responsible for directing and executing all commissioning activities for plant utility systems-including chilled water, heating hot water, plant steam/condensat...
Job Summary: The Supplier Quality Engineer is responsible for implementing Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing mater...
Requirements: BSME, Solidworks, Creo, Altium, electrical design platforms, GT-SUITE, thermal analysis platforms, computational fluids dynamics (CFD) platforms, combustion analysis platforms Experience operating and prototyping with a 3-D...
of experience in Computer System Validation (CSV) and System Development Life Cycle (SDLC). Experience working in FDA...
Summary: We're looking for an experienced CQV Engineer who enjoys owning equipment projects from concept to production in a highly regulated pharmaceutical environment. Responsibilities: This role is ideal for someone who is hands-on an...
Roles & Responsibilities: Provide lab system administration and support via the ticketing system (e.g., help requests, user access requests). Collaborate with lab analysts and end users to confirm problems or requests. Resolve issues or...
Responsibilities: The Principal Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environm...
Responsibilities: Analyses the system behavior and the interaction of single elements. Executes the hand-over to the customer personnel and their briefing. May make optimizations of disciplines (e.g. by settings). May contribute as tes...