Aseptic Process Validation Engineer
Listed on 2026-06-06
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job title
:
Aseptic Process Validation Engineer I
Location
:
Houston, TX (Onsite)
Duration
: 18 months, with the possibility to extend.
Interviews
: 2
Supports and collaborates with the project team for validation efforts right from inception, design build, test and implementation.
Investigate/troubleshoot validation discrepancies for systems and/or performance processes.
Support validation activities – IQ/OP/PQ.
Support ethylene oxide requalification activities to meet ISO requirements on time.
Create change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectiveness.
Ensures required processes and procedures are followed to support validation programs and are in compliance with regulations.
Co-operates with all departments through open, candid communication and collaboration.
Prior experience working with ethylene oxide and gamma sterilization processes.
Pharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to medical devices and surgical products.
Knowledge of statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.
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