Job Summary: The Manufacturing Validation Engineer will support medical device manufacturing operations by planning, executing, and documenting process, equipment, and measurement system validations. This role ensures compliance with ISO...
Responsibilities: Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets. Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specif...
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 s...
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...
Job Description: We are seeking an experienced Method Validation Engineer to support the development, validation, and implementation of analytical methods—primarily dissolution and particulate matter testing (USP 788 )—for a GMP release ...
Roles & Responsibilities: Develop quality assurance documentation for new product development and regulatory submissions. Maintain and improve quality system processes by identifying and correcting deficiencies. Engage in design, develo...
Job Description: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs acti...
Job Summary: We are seeking an experienced and highly skilled Lead Validation Engineer to support validation, quality, engineering, and manufacturing programs within a cGMP-regulated biopharmaceutical environment. The ideal candidate bri...
Job Description: The Manager, Quality Systems is responsible for providing end-to-end quality assurance oversight across designated manufacturing operations, which may include pharmaceutical products, medical devices, cosmetics, biologics...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...