Validation Engineer Breda • SIRE Life Sciences
Gevraagd
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37 - 40 uur
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Senior
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Engels (taal)
Aanbod
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Vast contract
Vacature in het kort
Over het bedrijf
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The Company
Our client is a multinational biotech company who strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.
Role Description
As a Validation Engineer, you will play a key role in ensuring that the equipment, systems, and processes meet strict regulatory requirements and perform consistently within defined specifications. You will work cross-functionally with departments such as Quality Assurance, Engineering, and Production to plan, execute, and document validation activities across the site.
Responsibilities
-Develop and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, cleaning, and processes
- Ensure compliance with GMP, FDA, EMA, and internal quality standards
- Conduct risk assessments and gap analyses
- Collaborate with project teams to support equipment and process qualification
- Review and approve validation documentation
- Participate in internal and external audits
- Provide technical guidance and training to colleagues on validation standards and procedures
Requirements
- Bachelor’s degree in engineering, pharmacy, life sciences, or related field
- Minimum 2–5 years of experience in validation within a GMP-regulated environment
- Strong understanding of validation lifecycle and regulatory expectations
- Excellent documentation, analytical, and communication skills
- Experience with risk-based validation approaches is a plus
- Proficient in English (spoken and written); Dutch is a plus
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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