/troubleshoot validation discrepancies for systems and/or performance processes Support validation activities – IQ/OP/PQ Create...
. Requirements: Bachelor's Degree (BSME preferred). Process Validation / IQ,OQ,PQ. Systems integration and Manufacturing process...
Experience with validation protocols, qualification processes (IQ/OQ/PQ), and change control management in regulated environments...
(IQ/OQ/PQ), including protocol creation and final reporting Evaluate prior validation work to determine opportunities...., FMEA) Basic understanding of validation or testing in a regulated environment (IQ/OQ/PQ) Exposure to Lean or continuous...
/OQ/PQ activities (including commissioning activities of new equipment or areas). Develop scope for capital projects...
, including IQ/OQ/PQ/PPQ protocols and reports. Participate in PFMEA activities, time studies, and value stream mapping exercises...
equipment qualification and process validation (IQ/OQ/PQ). Perform Test Method Validation and Software Validation for hardware...
conformance with standards and established quality requirements. Perform studies to support necessary equipment and system PQ...
validations, OQ/PQ studies, design of experiments, transit testing, aging studies, sterilization validations, and ongoing process...
protocols and summary reports, and traceability matrices. Review, coordinate, manage, and approve vendor IQ/OQ/PQ protocols...