Validation Engineer

The company is looking for a Validation Engineer to join its growing team in Kaunas. This is a newly created role, combining approximately 80–90% validation tasks and 10–20% machine safety responsibilities.

Key responsibilities

• Prepare and maintain validation documentation (FS, FDS, SDS, HDS, checklists, protocols, reports)
• Ensure compliance with CE, ISO (e.g., 12100, 13849), FDA, and GAMP standards
• Conduct risk assessments (pFMEA) and support machine safety concept development
• Coordinate internal and customer validation reviews
• Prepare FAT/SAT documentation and lead testing activities
• Collaborate closely with engineers from PM, ME, CE, AE teams, as well as Swiss and US colleagues
• Contribute to quality assurance practices and compliance documentation

• Bachelor’s or Master’s degree in a technical field (mechanical, mechatronics, automation, etc.)
• Some experience with documentation, validation, or quality-related tasks
• Understanding of machinery or automation systems
• Strong written English skills (minimum B2, ideally C1 – all documentation is in English)
• High attention to detail, responsibility, ability to work independently
• Proficiency in MS Office and general digital literacy

Nice to have

• Experience in pharmaceutical, medical device, or food manufacturing environments
• Familiarity with CE marking, ISO standards, FDA, or GAMP
• Knowledge of machine safety regulations and risk assessment
• Experience with FAT/SAT procedures
• French language skills

• A clearly defined role in a growing international engineering team
• Opportunity to work on-site with highly specialized, complex equipment
• Close collaboration with Swiss and US teams
• Friendly and supportive environment (32 employees locally, ~10 in engineering/project roles)
• Flexible working hours (start between 7:00–9:00), hybrid work (1–2 days/week from home)
• Internal time tracking with flexibility to accumulate +/- 80/20 hours
• Occasional business travel (approx. 10% annually), including trips of 2–3 weeks (e.g., to Switzerland)
• Private medical insurance and a modern, innovation-driven work environment