Freelance Validation Engineer

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