As a Validation Engineer, you’ll lead and support validation activities across manufacturing and software systems in a regulated environment. You'll work cross-functionally to ensure compliance, resolve issues, and maintain validation systems in alignment with industry standards.
Key Responsibilities:
* Plan and execute process and software validation activities
* Troubleshoot and resolve validation-related issues
* Maintain consistency across validation approaches and documentation
* Support change control processes and conduct periodic reviews
* Ensure compliance with GMP, regulatory, and H&S standards
Requirements:
* Degree (Level 7+) in Science, Engineering, or related field
* 2+ years' experience in Quality Assurance or Regulatory Affairs
* Strong background in process validation (CDRH guidance), GAMP 4/5, and statistical methods (DOE, DMAIC)
* Proficient in MS Office; strong technical writing skills
* Experience responding to regulatory inquiries and audits
Nice to Have:
* Previous experience in a medical device manufacturing setting
* Six Sigma Green or Black Belt certification
* Knowledge of electronic production processes
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