Validation Engineer in Helwith Bridge - CV-Library

Job Summary:

The Validation Engineer will play a critical role in ensuring that all medical devices and associated processes meet quality, regulatory, and performance requirements. This role involves developing and executing validation protocols, conducting testing, and ensuring compliance with industry standards, such as ISO 13485, FDA regulations, and GMP guidelines.

Key Responsibilities:

Develop, write, and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software used in medical device manufacturing.
Perform process validation and re-validation activities to ensure continued compliance.
Prepare and review validation reports, ensuring clear and accurate records of all testing and findings.
Maintain detailed documentation of validation activities to support audits and regulatory submissions.
Ensure all validation processes meet regulatory requirements, including FDA, ISO 13485, and other applicable standards.
Participate in internal and external audits to demonstrate compliance.
Perform risk assessments (e.g., FMEA) to identify and mitigate potential issues during validation.
Analyze test results and provide recommendations for process improvements.
Qualifications and Experience:

Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) or equivalent experience.
2+ years in validation engineering within the medical device or pharmaceutical industry.
Familiarity with regulatory frameworks (e.g., FDA 21 CFR Part 820, ISO 13485).
Strong understanding of validation processes, including equipment and process validation.
Experience with quality tools such as FMEA, Root Cause Analysis, and CAPA.
Proficiency in technical writing and documentation.
Excellent problem-solving and analytical skills.
Ability to work independently and as part of a team.
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For more information and a confidential chat please contact Niall Finnerty on (phone number removed)/ (url removed)