Injection Molding Validation & CSV Engineer

HonorVet Technologies

Houston (TX)

On-site

USD 80,000 - 110,000

Full time

3 days ago

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Job summary

HonorVet Technologies is seeking a contract Injection Molding Process Engineer I to support medical device molding operations in Houston. The role emphasizes validation across software, automation, and manufacturing systems with experience in Kneat and CSV tied to quality systems.

The engineer will validate equipment, tooling, and digital systems, applying statistics and PDP methods while collaborating with Quality, Manufacturing, and Engineering to ensure FDA/ISO compliance and data integrity.

Qualifications

Bachelor's degree in a technical field related to engineering or manufacturing.
Experience with injection molding processes in a regulated environment.
Proven validation experience (IQ/OQ/PQ) and computer system validation.
Familiarity with Kneat or similar electronic validation platforms.
Strong statistical and data analysis skills.

Responsibilities

Develop, execute, and document process validation protocols for molding equipment and tooling.
Lead or support CSV and automation/equipment validation activities for molding systems.
Manage validation documentation within Kneat or similar systems.
Apply statistical methods to support process capability studies and improvements.
Collaborate with Quality, Manufacturing, and Engineering to ensure regulatory compliance.
Investigate deviations and write audit-ready documentation.
Support validation of MES, LIMS, electronic batch records, and PLM tools.
Use SAP to support production orders and manufacturing data.
Query manufacturing/quality data with SQL for analysis and reporting.