Blow Molding Equipment Validation Engineer

Job Description & Skill Requirement:

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