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