Lead the qualification and validation of blow molding equipment by developing and executing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports
Experience:
4–8 years of experience in manufacturing engineering, process validation, or equipment validation within a regulated industry. Minimum 3 years of hands-on experience with blow molding equipment (Extrusion, Injection, or Stretch Blow Molding). Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments is preferred.
Technical Skills:
Strong knowledge of equipment qualification (IQ/OQ/PQ), process validation, and validation lifecycle management.
Experience with medical-grade polymer processing and blow molding technologies. Proficiency in statistical analysis tools such as Minitab, SPC, Cp/Cpk, DOE, and Measurement System Analysis (MSA). Familiarity with PLC-controlled manufacturing equipment, automation systems, SCADA/HMI, and vision inspection systems. Experience with change control, CAPA, nonconformance investigations, and engineering documentation.
Qualification:
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Plastics Engineering, Mechatronics, or a related engineering discipline