Sr. Engineer- Automation
validation processes, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance...
validation processes, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance...
and optimize processes and tooling through IQ/OQ/PQ, Gage R&R studies, process capability studies, and design of experiments...
with medical device validation (IQ-OQ-PQ). Basic understanding of statistical methods (e.g., Cpk, Hypothesis Testing, DOE’s, Gage...
validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practices (GDP) Preferred...
to requirements Plan and execute process validation: characterization, OQ/PQ, TMVs/measurement systems, statistical process control...
activities, including IQ, OQ, and PQ protocols and test method development and validation. Support automation initiatives...
;Mechanical, Nuclear or Manufacturing Engineering Technology;or Physics Preferred Qualification “PQ” - Bachelor's Degree...
supporting equipment qualification (IQ/OQ/PQ). Experience with aseptic processing is a plus. Experience with CDMOs and external...
;recommends changes to equipment, product or test methods. Sets-up qualification testing (IQ/OQ/PQ) Install, repair, modify...
Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Computer System Validation (CSV) Validation...