Aseptic Process Validation Engineer
Listed on 2026-06-04
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Engineering
Quality Engineering, Validation Engineer, Biomedical Engineer
Join Our Team as a Validation Engineer in Houston, TX!
Are you passionate about ensuring the highest standards in pharmaceutical and medical device manufacturing? We are seeking a skilled Validation Engineer to support our aseptic process validation efforts. This role offers a unique opportunity to work in the vibrant city of Houston, TX, known for its diverse culture and thriving industries.
Job Responsibilities- Collaborate with project teams for validation efforts from inception to implementation.
- Investigate and troubleshoot validation discrepancies in systems and performance processes.
- Support validation activities, including IQ/OP/PQ processes.
- Assist in ethylene oxide requalification activities to meet ISO standards.
- Create change controls and assist in determining root causes for non-conforming events.
- Ensure compliance with validation programs and regulatory standards.
- Communicate and collaborate effectively with various departments.
- Prior experience with ethylene oxide and gamma sterilization processes.
- Familiarity with Pharmaceutical Industry GMPs and the ability to interpret and apply ISO 11135, 11137, TIR 15, TIR 28, 11737, and relevant FDA and country-specific guidelines.
- Knowledge of statistical analysis for risk management and quality control.
- Experience in the medical devices and surgical industry.
- Strong problem-solving skills and a proactive approach to troubleshooting.
If you're ready to make an impact in the pharmaceutical and medical device industry, apply now to join our dynamic team in Houston, TX. Your expertise can help us ensure the highest product quality and safety standards.
Subject Line: Exciting Opportunity for a Validation Engineer in Houston
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