Education & Experience : Bachelor's degree in Engineering, LifeSciences, or related field 5-8+years of CSV experience...
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...
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...
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...
of experience in Computer System Validation (CSV) and System Development Life Cycle (SDLC). Experience working in FDA...
Responsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. Be responsible for overall project delivery, including clinical trial reports and other regulatory submission delivera...
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...
Responsibilities: Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies. Assesses study datasets an...
Job Summary We are seeking a Senior Supplier Quality Engineer to join our Supplier Quality Engineering team as a consultant. The role is within the Medical Devices / Orthopedics manufacturing domain, supporting external manufacturing suppl...
Job Description: The Dispensing Technician supports the manufacturing of therapeutic proteins (API) by accurately dispensing raw materials-liquids, powders, acids, and bases-under cGMP conditions. This role requires precision, compliance, ...