Sterilization Engineer
Aequor JD ·www.aequor.com
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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
Author and coordinate validation protocols– IQ/OQ/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
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.
1-3 years working experience in medical device manufacturing or similar GMP environment
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 the medical devices and surgical.
Good communication skills and able to lead a team.
Investigate/troubleshoot validation discrepancies for systems and/or performance processes
Author and coordinate validation protocols– IQ/OQ/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
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.
1-3 years working experience in medical device manufacturing or similar GMP environment
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 the medical devices and surgical.
Good communication skills and able to lead a team.
Frequently asked questions
Who is hiring for the Sterilization Engineer role?
Aequor JD is hiring for the Sterilization Engineer position, a Shazamme client. Apply directly on the employer's career site.
Where is the Sterilization Engineer job located?
The Sterilization Engineer role with Aequor JD is based in Houston, TX, US.
Is the Sterilization Engineer role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Sterilization Engineer role?
The Sterilization Engineer position is aimed at mid-level candidates.
How do I apply for the Sterilization Engineer role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.