Freelance Validation Engineer
Freelance Validation Engineer (Process Validation)
Location: Budapest area, Hungary
Contract Length: 6 months (high-intensity project through December)
Hours: 40 hours per week
Working Model: Primarily on-site initially, transitioning to ~50/50 hybrid
Overview
We are supporting a leading medical device manufacturer in Hungary who require a Freelance Validation Engineer to support a significant validation programme during a peak activity period.
The focus of the role will be process validation of new machines and new product design, ensuring compliance within a GMP-regulated manufacturing environment.
Key Responsibilities
- Lead and support process validation activities for new equipment and new product introductions
- Execute validation lifecycle activities including IQ/OQ/PQ and associated validation steps
- Validate automated manufacturing systems, including vision system controls
- Ensure all validation activities comply with GMP and relevant regulatory standards
- Support development and execution of validation protocols, reports, and documentation
- Work closely with Engineering, Quality, and Manufacturing teams during validation execution
- Apply statistical methods to support validation studies and process capability
Key Requirements
- Proven experience in process validation within medical devices or regulated manufacturing
- Strong knowledge of GMP and validation lifecycle (IQ/OQ/PQ)
- Experience validating automated systems / vision systems
- Solid statistical knowledge (e.g. process capability, data analysis)
- Fluent in Hungarian and English (essential)
Additional Information
- The role will require consistent on-site presence initially due to the nature of the validation work
- Hybrid flexibility (approx. 50/50) can be introduced after the initial phase
- This is a time-critical project with peak workload through to December
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