Validation Engineer – Innovative company!

Location:

Amersfoort – Utrecht, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Manufacturing Jobs

Advertiser:

NonStop Consulting

Job ID:

131423572

Posted On:

16 December 2024

Job Title: Validation Engineer – Medical Device Industry

Location: Amersfoort Region, The Netherlands

Company Overview:
Join a pioneering medical device company based in the Amersfoort region, committed to developing innovative healthcare solutions that improve lives. Our focus on quality, safety, and regulatory compliance ensures that we deliver products that meet the highest industry standards.

Position Overview:
We are seeking a highly skilled Validation Engineer to support our manufacturing and quality assurance operations. In this role, you will ensure the validation and compliance of processes, equipment, and systems critical to the production of our medical devices.

Key Responsibilities:

* Develop and implement validation protocols (IQ, OQ, PQ) for equipment, manufacturing processes, and software systems.
* Ensure compliance with applicable regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR).
* Collaborate with cross-functional teams to ensure validation activities align with business goals and timelines.
* Analyze validation test results, identify risks, and recommend process improvements.
* Prepare and review detailed validation plans, reports, and supporting documentation.
* Conduct training sessions to educate team members on validation processes and regulatory requirements.
* Support CAPA activities related to validation, performing root cause analyses and implementing corrective actions.
* Stay informed about industry best practices and regulatory updates to ensure continuous compliance.

Qualifications:

* Bachelor’s degree in Engineering, Life Sciences, or a related field.
* Minimum of 3 years of experience in validation engineering within the medical device or pharmaceutical industry.
* Strong knowledge of validation methodologies, including risk management and statistical analysis tools (e.g., FMEA, DOE).
* Familiarity with regulatory frameworks (ISO 13485, FDA, EU MDR) and GMP standards.
* Excellent technical writing skills, with experience drafting validation documentation.
* Strong analytical, organizational, and problem-solving abilities.
* Proficiency in English (spoken and written); Dutch language skills are a plus.

Preferred Skills:

* Experience with software validation (e.g., ERP, LIMS, MES).
* Certification in Quality Engineering (CQE) or similar credentials.
* Hands-on experience with statistical tools (e.g., Minitab, JMP).

What We Offer:

* Competitive salary and comprehensive benefits package.
* Professional development opportunities and a chance to advance your career.
* A dynamic and collaborative work environment in the heart of the Amersfoort region.
* The opportunity to contribute to life-changing healthcare innovations.

How :
If you’re ready to make a meaningful impact in the medical device industry, please submit your resume and cover letter to (email address or application portal link).

We are an equal opportunity employer and encourage candidates from diverse backgrounds .

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