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...
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...
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 ...
experience with Unix and Windows operating systems Understanding of the software development life cycle Understanding of FDA...
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...
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...
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...
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...
Job Summary: The GxP IT Systems Support / CSV Technical Contractor provides hands-on IT support for computerized systems used in GxP operations at the Coral Springs site. This role focuses on system administration, technical troubleshoot...
Roles & Responsibilities: Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC. Supp...