Senior Manufacturing Engineer
equipment issues. Experience with process validation documentation including PFMEA, IQ, TMV, OQ/PQ, and statistical analysis...
equipment issues. Experience with process validation documentation including PFMEA, IQ, TMV, OQ/PQ, and statistical analysis...
and efficiency across dealer parts operations as well as internal Parts programs, such as employee parts purchases. Work with PQ...
filling operations Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ) Process optimization...
(temperature, RH, pressure, flow) and support IQ/OQ/PQ with solid validation documentation. Drive investigations and CAPA using...: Sensor calibration, IQ/OQ/PQ, GDP, CAPA, Change Control. Diagnostics: Advanced troubleshooting, basics of vibration analysis...
engineering, PQ input, and data release requirements. Follow and contribute to the development of common GM Global Design...
IQ/OQ/PQ execution and other validation activities as needed. Collaborate with Engineering and Quality to investigate...
, test method validations, and manufacturing process validation deliverables, with emphasis on TMVs and OQ/PQ protocol... protocol execution, report writing, and review of Test Method Validation and OQ/PQ documentation. Experience with FMEAs, risk...
. Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports...), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary...
, and manufacturing readiness. Establish validation requirements and develop or approve IQ/OQ/PQ documentation at suppliers... and functional testing, and packaging interfaces. Experience with process validation (IQ/OQ/PQ), first article inspection...
would be a plus if you also possess previous experience in: Knowledge of validation activities such as equipment and process qualifications (IQ, OQ, PQ...