, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP. Able to recognize non-conformances from accepted and documented practices...
(i.e., validation including IQ/OQ/PQ, CPAP, or related) Sourcing including component qualification Quality engineering including new...
validation protocols (IQ / OQ / PQ / MSA) Exceptional project management and team leadership skills. Physical...
) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ..., operational and performance qualification (IQ/OQ/PQ) protocols Ability to use AutoCAD, Revit, Visio Engineering, communication...
equipment and processes. You will review and approve equipment acceptance testing (FAT/SAT) and validation protocols (IQ/OQ/PQ...
) principles to enhance product reliability and reduce manufacturing costs. Conduct process validation, including IQ, OQ, and PQ..., OQ, and PQ Experience with advanced manufacturing technologies and processes, such as additive manufacturing, automation...
and with CoE’s, Cell Therapy IT, and Quality on CSV for plant applications in supporting of IQ/PQ protocols Provide IT Hypercare...
for automation equipment. Create protocol documentation for equipment DQ, IQ, OQ, PQ Validation as needed. Additional responsibility... execution and support of DQ/IQ/OQ/PQ protocols. Hands on manufacturing line support when needed, including the debug, repair...
Analysis (PFMEA), developing Process Control Plans (PCP) and Process Validations (IQ/OQ/PQ). Is informed about advancement in...
and PQ; Assist with alignment of local procedures and practices with Corporate and regulatory requirements. Documents may...