experience with Unix and Windows operating systems Understanding of the software development life cycle Understanding of FDA...
Summary: Knowledge and experience in product development / NPD is preferred. Design and develop electro-mechanical systems and components. Perform system integration of mechanical and electrical parts. Identifying and using stepper moto...
Responsibilities: Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensur...
Summary: This is a hands-on, onsite role focused on equipment installation, IQ/OQ execution, and validation documentation within a regulated manufacturing environment (ISO 9001 / ISO 13485). The team is looking for someone who can support ...
Summary : We are looking a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products, including infusion systems and drug-device delivery platforms. This role wor...
readiness team in a timely and professional manner. Requirements: Bachelor's degree in a scientific discipline such as life... sciences, pharmacy, bioscience;advanced degree preferred. 5+years of experience in regulatory affairs within the...
Roles and Responsibilities: Lead end-to-end Computer System Validation for GxP systems. Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports. Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP. M...
Responsibilities: Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental proced...
Job Description: The HR Generalist - Recruiting Focus will support a pharmaceutical manufacturing site undergoing rapid growth. This role is primarily responsible for high-volume recruiting execution, partnering closely with hiring manager...
Job Description: We are looking for a Project Manager with a strong understanding or prior experience in Packaging Technology to lead projects focused on cost savings, sustenance, and Value Engineering / Value Analysis (VE/VA). This role c...