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.

Please share your updated resume at [email protected] if you're interested.

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

Thanks & Regards,

Haritha
Sourcing Specialist
Intellectt Inc.
[email protected]
Desk: (phone hidden) Ext: 318

📌 Blow Molding Equipment Validation Engineer (Ciudad Juárez)
🏢 Intellectt
📍 Ciudad Juárez