Blow Molding Equipment Validation Engineer

Intellectt INC; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

Intellectt Inc in Juarez, Mexico is seeking an experienced Blow Molding Equipment Validation Engineer to lead qualification activities for regulated manufacturing.

You will drive IQ/OQ/PQ protocols, prepare validation reports, and collaborate with manufacturing, quality, and design teams to ensure compliant processes and continuous improvement.

Formación

• Bachelor's degree in an engineering discipline (Mechanical, Manufacturing, Industrial, Plastics, Mechatronics)
• 4–8 years in manufacturing engineering, process validation, or equipment validation in regulated industry
• Minimum 3 years hands-on experience with blow molding equipment (Extrusion, Injection, or Stretch Blow Molding)
• Experience in medical device, pharmaceutical, biotechnology, or other highly regulated environments preferred
• Strong knowledge of IQ/OQ/PQ, process validation, and validation lifecycle management
• Experience with medical-grade polymer processing and blow molding technologies
• Proficiency with statistical tools including Minitab, SPC, Cp/Cpk, DOE, and MSA
• Familiarity with PLC-controlled equipment, automation, SCADA/HMI, and vision inspection systems
• Experience with engineering documentation, change control, CAPA, and nonconformance investigations

Responsabilidades

• Lead qualification and validation of blow molding equipment by developing and executing IQ, OQ, and PQ protocols
• Prepare and execute Validation Summary Reports and maintain validation documentation
• Support process validation activities and ensure compliance with regulated standards
• Perform equipment validation lifecycle management, including change control and continuous improvement
• 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 MSA
• Support investigations related to CAPA, nonconformances, and manufacturing deviations
• Work with PLC-controlled equipment, automation systems, SCADA/HMI, and vision inspection systems

Conocimientos

Statistical analysis

Validation lifecycle management

CAPA & nonconformance investigations

Cross-functional collaboration

Educación

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Plastics Engineering, Mechatronics, or related

Herramientas

Minitab

SPC

Cp/Cpk

DOE

MSA

PLC/SCADA

Descripción del empleo

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 ideal 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