Validation Engineer (Open)

The Validation Engineer is responsible for the planning, execution, documentation, and lifecycle management of validation activities, including equipment qualification (IQ/OQ/PQ), process validation, and software/tool validation, in compliance with ISO 13485, EU MDR (Medical Device Regulation), and FDA 21 CFR Part 820 requirements.

This role is essential to ensuring that production equipment and processes used for Class III implantable medical devices consistently operate within defined parameters and meet quality and regulatory requirements.

The Validation Engineer:

1. Validation activities

• Author, execute, and maintain IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for production equipment;
• Plan and perform process validation (including prospective, concurrent, and retrospective) in accordance with regulatory and internal quality requirements;
• Perform Test Method Validation (TMV) and equipment/software validation;
• Excecute the Process Validation Plans (PVP) and validation protocols;
• Manage re-validation activities upon equipment or process changes.

2. Documentation and compliance

• Ensure all equipment qualification and validation activities are properly documented, reviewed, and approved according to regulatory requirements (e.g., ISO 13485, GMP, FDA) and internal SOPs;
• Participate in internal and external audits and provide validation documentation as required;
• Support risk management activities, including validation impact assessments.

3. Cross-Functional Collaboration

• Provide technical expertise in integrating validation engineering into product and manufacturing workflows.
• Work closely with R&D, Quality, and Manufacturing teams to support new product introductions and technology transfers;
• Assist in the transfer of manufacturing operations to external contract manufacturers or in-house commercial manufacturing sites;
• May be effectively involved in production and QC activities during validation and/or process development and/or validation.

• Support the development and improvement of validation procedures, templates, and training;
• Participate in non-conformity investigations, CAPA processes, and change control processes.

5. Regulatory & Compliance Support

• Support documentation and regulatory submissions (e.g., CE Mark, 510(k), IDE, PMA) by providing technical insights on process design and validation;
• Address and remediate quality and compliance issues, including NCRs, CAPAs, and supplier quality challenges.

The Validation Engineer must have the following requirements:

• Bachelor’s degree in Engineering ((Biomedical, Mechanical, Chemical, or equivalent) or a related technical discipline; an advanced degree (Master’s) is preferred;
• Minimum of 3 years of experience in validation within regulated medical device environnement, 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;
• Proven ability to execute cross-functional technical projects;
• Strong technical writing and documentation skills in English;
• Knowledge of cleanroom qualification and environmental monitoring;
• Understanding of statistical methods (e.g., Gage R&R, capability studies, sampling plans);
• Successful experience with project and program management. Proven experience working with quality system tools and professionals to ensure highly reliable processes.

We keep an eye out for people with strong skills in chemistry, biology and biomaterials as openings occur. If you would like to be considered for openings in these areas, please email your resume and interests