Summary : 3+years of mechanical engineering experience Strong experience doing Equipment walkdowns in a Pharma environment. Must have extensive plant walkdown capabilities to ensure documentation reviews are done correctly. Candi...
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 & Responsibilities: Develop tool and die concepts based on specific manufacturing needs and customer specifications. Create detailed designs, blueprints, 3D models, and flat blank geometry for laser cutting using SolidWorks/LogoPre...
Job Summary: 5+years of experience as a Validation Professional. Strong experience in Computerized System Validation (CSV). Hands-on experience with FactoryTalk PharmaSuite. Experience developing and executing validation protocol...
CQV START UP/COMMISSIONING MECHANICAL ENGINEER Requirements: 4+years of experience with mechanical utilities including boilers, chillers, generators etc. Start-up experience in a Pharma environment for Mechanical utilities (boilers,...
Job Summary: Lab Equipment Validation Engineer responsible for leading validation activities for laboratory equipment supporting infusion system testing in a regulated medical device environment, ensuring compliance with FDA regulations, ...
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: Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...
Summary: Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance ...
) and EBRs (i.e. InfoBatch). Understanding of Computer System Validation (CSV). Bachelor's degree in a lifesciences...