The Validation Engineer is responsible for planning, executing, documenting, and managing validation activities, including equipment qualification (IQ/OQ/PQ), process validation, and software/tool validation, in compliance with ISO 13485, EU MDR, and FDA 21 CFR Part 820 requirements.
This role ensures that production equipment and processes for Class III implantable medical devices operate within defined parameters, meeting quality and regulatory standards.
The Validation Engineer:
1. Validation activities
* Author, execute, and maintain IQ, OQ, and PQ protocols for production equipment;
* Plan and perform process validation (prospective, concurrent, retrospective) according to regulatory and internal quality standards;
* Perform Test Method Validation (TMV) and validation of equipment/software;
* Execute Process Validation Plans (PVP) and validation protocols;
* Manage re-validation activities following equipment or process changes.
2. Documentation and compliance
* Ensure proper documentation, review, and approval of validation activities per regulatory requirements and SOPs;
* Participate in audits and provide validation documentation;
* Support risk management activities, including validation impact assessments.
3. Cross-Functional Collaboration
* Provide technical expertise for integrating validation engineering into product and manufacturing workflows;
* Collaborate with R&D, Quality, and Manufacturing teams for new product introductions and technology transfers;
* Assist in transferring manufacturing operations to external or in-house sites;
* Support validation-related production and QC activities;
* Help develop and improve validation procedures, templates, and training;
* Participate in non-conformity investigations, CAPA, and change control processes.
4. Regulatory & Compliance Support
* Support documentation and submissions (e.g., CE Mark, 510(k), IDE, PMA) with technical insights;
* Address quality and compliance issues, including NCRs, CAPAs, and supplier challenges.
The candidate must have:
* Bachelor’s degree in Biomedical, Mechanical, Chemical Engineering, or related; Master’s preferred;
* At least 3 years of validation experience in regulated medical device environments, preferably Class III;
* Knowledge of ISO 13485, EU MDR, and FDA 21 CFR Part 820;
* Familiarity with GxP, risk-based validation, and design control principles;
* Proficiency in Microsoft Office and validation tools;
* Strong technical writing skills in English;
* Knowledge of cleanroom qualification and environmental monitoring;
* Understanding of statistical methods (Gage R&R, capability studies, sampling);
* Experience with project management and working with quality systems.
We are also interested in candidates with strong skills in chemistry, biology, and biomaterials. If interested, please email your resume and interests.
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