Job Description. Performs routine set up, operation, minor routine maintenance, preventative maintenance (PM) and troubleshooting of moderately complex/automated manufacturing equipment. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective products, packaging, and component material. Checks work using prescribed gauges, jigs, and fixtures to measure close tolerances. Responsibilities....
Responsibilities. The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regu...
Job Description. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements. The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validat...
Job Summary. The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment. This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific require...
Job Description. The Program CSV Consultant will provide strategic guidance and oversight during the planning and setup of CSV deliverables for the client's Foundry Program. Responsibilities. Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning. Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans...
Responsibilities. The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards. The Regulatory Affairs position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo d...
Roles & Responsibilities. Develop and execute validation strategies. Lead Process Validation & PPQ activities. Perform C&Q for equipment, utilities, and facility systems. Run risk and gap assessments. Maintain equipment master data and support change controls. Execute floor-level validation in GMP cleanrooms. Coordinate sampling and data collection. Support recipe authoring, data trending, and automation needs. Train and guide cross-functional te...
Roles & Responsibilities. Develop and execute validation strategies. Lead Process Validation & PPQ activities. Perform C&Q for equipment, utilities, and facility systems. Run risk and gap assessments. Maintain equipment master data and support change controls. Execute floor-level validation in GMP cleanrooms. Coordinate sampling and data collection. Support recipe authoring, data trending, and automation needs. Train and guide cross-functional te...
Job Description. Our LSS Designers are responsible for the delivery of complex packages in coordination with multi-disciple engineers and design leads that form the core of our Life Safety Systems delivery team. Utilizing AutoCAD and Revit MEP, you'll create a 3D model space in coordination with architects and engineers. From those 3D BIM models you'll assist the designers with layouts for Fire Alarm Detection Systems, HPM leak detection, Toxic G...
Job Description. Our LSS Designers are responsible for the delivery of complex packages in coordination with multi-disciple engineers and design leads that form the core of our Life Safety Systems delivery team. Utilizing AutoCAD and Revit MEP, you'll create a 3D model space in coordination with architects and engineers. From those 3D BIM models you'll assist the designers with layouts for Fire Alarm Detection Systems, HPM leak detection, Toxic G...
Summary. We're looking for a Sr. Manufacturing Engineer to lead and execute CNC equipment/process validation in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability, this is a strong opportunity. Roles And Responsibilities. Lead validation for CNC machines (mills, lathes, multi-axis) and tooling/work holding. Author and maintain IQ/OQ/PQ protocols & reports validation documentation. S...
Summary. We're looking for a Sr. Manufacturing Engineer to lead and execute CNC equipment/process validation in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability, this is a strong opportunity. Roles And Responsibilities. Lead validation for CNC machines (mills, lathes, multi-axis) and tooling/work holding. Author and maintain IQ/OQ/PQ protocols & reports validation documentation. S...
