I3 INFOTEK INC
Overview
Job Title:
Manufacturing Process Validation Engineer Position Summary: The Manufacturing Process Validation Engineer will lead and execute
process validation activities
for a state-of-the-art manufacturing facility. This senior technical role ensures that manufacturing processes, equipment, and tooling meet
regulatory and quality requirements , supporting product quality, efficiency, and compliance. Responsibilities
Lead
Manufacturing Process Validation
including
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
for equipment, tooling, and production lines. Develop and execute
Test Method Validations
(e.g., Gage R&R) and generate detailed validation reports. Coordinate with
suppliers
for purchase, delivery, installation, and qualification of equipment and tooling. Develop, review, and approve
SOPs, manufacturing procedures, and process documentation . Conduct
component qualifications, process characterizations, and Design of Experiments (DOE) . Perform
manufacturing capacity analysis
and provide recommendations for process optimization. Support
root cause analysis, process improvements, and preventive maintenance planning . Ensure compliance with
cGMP, ISO 13485, and internal quality standards . Communicate effectively in
English and Spanish
across all levels and cross-functional teams. Required Qualifications
Education:
Bachelor’s or Master’s degree in Engineering or related field. Experience:
10+ years in
engineering roles
with a focus on
medical device manufacturing and process validation . Language:
Proficient in
English and Spanish . Technical Skills / Expertise
Process Validation:
IQ, OQ, PQ, mold validation, DOE Regulatory Compliance:
cGMP, 21 CFR Part 820, ISO 13485 Cross-functional Communication:
Supplier coordination, team collaboration, bilingual communication Seniority Level
Senior-Level / Lead Engineer – responsible for technical leadership in process validation and cross-functional manufacturing activities. Employment type
Contract Job function
Management Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Appliances, Electrical, and Electronics Manufacturing Location: El Paso, TX Salary: $63,000.00-$78,800.00
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Job Title:
Manufacturing Process Validation Engineer Position Summary: The Manufacturing Process Validation Engineer will lead and execute
process validation activities
for a state-of-the-art manufacturing facility. This senior technical role ensures that manufacturing processes, equipment, and tooling meet
regulatory and quality requirements , supporting product quality, efficiency, and compliance. Responsibilities
Lead
Manufacturing Process Validation
including
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
for equipment, tooling, and production lines. Develop and execute
Test Method Validations
(e.g., Gage R&R) and generate detailed validation reports. Coordinate with
suppliers
for purchase, delivery, installation, and qualification of equipment and tooling. Develop, review, and approve
SOPs, manufacturing procedures, and process documentation . Conduct
component qualifications, process characterizations, and Design of Experiments (DOE) . Perform
manufacturing capacity analysis
and provide recommendations for process optimization. Support
root cause analysis, process improvements, and preventive maintenance planning . Ensure compliance with
cGMP, ISO 13485, and internal quality standards . Communicate effectively in
English and Spanish
across all levels and cross-functional teams. Required Qualifications
Education:
Bachelor’s or Master’s degree in Engineering or related field. Experience:
10+ years in
engineering roles
with a focus on
medical device manufacturing and process validation . Language:
Proficient in
English and Spanish . Technical Skills / Expertise
Process Validation:
IQ, OQ, PQ, mold validation, DOE Regulatory Compliance:
cGMP, 21 CFR Part 820, ISO 13485 Cross-functional Communication:
Supplier coordination, team collaboration, bilingual communication Seniority Level
Senior-Level / Lead Engineer – responsible for technical leadership in process validation and cross-functional manufacturing activities. Employment type
Contract Job function
Management Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Appliances, Electrical, and Electronics Manufacturing Location: El Paso, TX Salary: $63,000.00-$78,800.00
#J-18808-Ljbffr