23 ago
|
Intellectt
|
Ciudad Juárez
23 ago
Intellectt
Ciudad Juárez
Hello,
I hope you're doing well.
My name is Haritha , and I'm reaching out from Intellectt Inc regarding an exciting opportunity for a Blow Molding Equipment Validation Engineer with one of our prestigious clients.
Job Title: Blow Molding Equipment Validation Engineer
Location: Juarez, Mexico (Onsite)
Job Summary:
We are seeking an experienced Blow Molding Equipment Validation Engineer with a strong background in equipment qualification, process validation, and blow molding technologies within a regulated manufacturing environment. The adecuado candidate will have hands‑on experience with IQ/OQ/PQ validation activities, medical‑grade polymer processing, PLC‑controlled equipment, and validation lifecycle management.
Key Responsibilities:
Lead the qualification and validation of blow molding equipment by developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
Prepare and execute Validation Summary Reports and maintain complete validation documentation
Support process validation activities and ensure compliance with regulated manufacturing standards
Perform equipment validation lifecycle management, including change control and continuous improvement activities
Collaborate with cross‑functional teams to troubleshoot equipment issues and implement process improvements
Analyze process data using statistical tools such as Minitab, SPC, Cp/Cpk, DOE, and Measurement System Analysis (MSA)
Support investigations related to CAPA, nonconformances, and manufacturing deviations
Work with PLC‑controlled equipment, automation systems, SCADA/HMI, and vision inspection systems
Requirements:
Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Plastics Engineering, Mechatronics, or a related engineering discipline
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 preferred
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 with statistical analysis tools including Minitab, SPC, Cp/Cpk, DOE, and MSA
Familiarity with PLC‑controlled manufacturing equipment, automation systems, SCADA/HMI, and vision inspection systems
Experience with engineering documentation, change control, CAPA, and nonconformance investigations
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📌 Blow Molding Equipment Validation Engineer (Ciudad Juárez)
🏢 Intellectt
📍 Ciudad Juárez