manufacturing environment. Key Responsibilities Execute SAT, IQ/OQ/PQ, and equipment validation activities Troubleshoot PLCs...
, and validation (CQV) activities for 3DP equipment. Execute and review validation documentation including IQ, OQ, and PQ protocols... with equipment validation and commissioning activities. Proven experience in process validation (IQ/OQ/PQ execution). Familiarity...
qualification (PQ), gauge repeatability and reproducibility (GR&R), and production part approval process (PPAP) Develop detailed... qualification (IQ/OQ/PQ) and production part approval process (PPAP) at contract manufacturers Knowledge of relevant standards...
systems compliance within FDA-regulated and EU MDR environments. Skilled in IQ/OQ/PQ validation, process characterization...: Support and execute process validation lifecycle activities including Process Characterization, IQ, OQ, and PQ validations...
. Must Have Experience in equipment IQ Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process...
, SolidWorks) Equipment validation (IQ/OQ/PQ) Automation, robotics, and mechatronics PLC programming (Siemens, Allen Bradley...
. Working knowledge of process validation activities (IQ/OQ/PQ) and fixture validation. Exposure to continuous improvement...
validation documentation including: Validation Plans User Requirements Specifications (URS) Risk Assessments IQ/OQ/PQ...
(URS) Functional/Design Specifications (FS/DS) Risk Assessments IQ/OQ/PQ Protocols Traceability Matrix Validation...
(IQ/OQ/PQ) PPAP (Production Part Approval Process), FAI (First Article Inspection), and PSW (Part Submission Warrant...