Principal Engineer Quality

Job Summary Job Description Job Responsibilities • • Act as site Subject Matter Expert (SME) for validation of equipment, sterile packaging, mixing, water systems (PW/WFI, distribution loops), filling systems (aseptic and non-aseptic), cleaning processes (CIP/COP, manual cleaning validation), and injection molding processes. • Define critical process parameters (CPPs) and critical quality attributes (CQAs) for complex manufacturing processes using risk-based approaches. • Draft, review, approve and finalize IQ , OQ , PQ protocols and validation reports for medical device production equipment, testing equipment and facility utilities. • Lead and oversee on-site validation execution, verify test data integrity, accuracy and traceability.…