22 ago
|
Intellectt
|
Ciudad Juárez
22 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 idóneo 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
#J-18808-Ljbffr
📌 Blow Molding Equipment Validation Engineer (Ciudad Juárez)
🏢 Intellectt
📍 Ciudad Juárez