Job Summary: The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes. The role ensures compliance with FDA QSR (21 CFR 820), ISO 13485, a...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...
Roles & Responsibilities: Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for proce...
Strong understanding of medical device product life cycle and regulatory requirements In-depth knowledge of ISO 13485, FDA regulations...
, and system life cycle documentation. Staying aligned with the project schedule and escalating risks or roadblocks early...
Responsibilities: Develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD Guarantee quality of statistical output produced by external provider, to program tools to support data ...
Job description: Collects environmental and utility samples for microbiological and chemical testing. Performs microbiological testing on water and swabs. Responsibilities: Implements, maintains, and makes changes to create global solu...
Responsibilities: Support Mechanical Design Optimization Projects: Contribute to projects aimed at improving our engineering and manufacturing processes. Data Collection and Analysis: Collect and process raw data and conduct analysis to ...
in lifesciences, health informatics, computer science, or related field. Advanced degree preferred. Strong understanding...
: Bachelor's degree in engineering, LifeSciences, or a related field. 5+years of relevant experience in validation...