Validation Engineer - Pharma and Medical sector

Responsibilities

• ▹URS, DQ, FAT, SAT, IQ, OQ, PQ documentation handling
• ▹Develop validation protocols for systems, equipment and/or processes
• ▹Execute qualification protocols for installation (IQ), operational performance (OQ) and performance load (PQ)
• ▹Execute risk assessments and gap analyses on systems or processes, pFMECA, hazard analysis
• ▹Ensure documentation complies with industry regulations (e.g., FDA, ISO, GMP)
• ▹Identify and report any validation deviations and propose corrective actions in collaboration with QA functions

Requirements

• ▹Minimum +6 years of experience in validation, quality assurance, or a related role in industries such as MedTech, pharmaceuticals, biotechnology, medical devices or manufacturing
• ▹Minimum Bachelor's degree in Engineering (e.g. mechanical engineering, production engineering or similar)
• ▹Experience designing and executing tests, writing and reviewing scientific documents with high technical complexity
• ▹Proficiency in validation tools and software
• ▹Knowledge of regulatory standards (FDA, GMP, ISO, etc.)
• ▹Familiarity with statistical analysis and risk assessment programs
• ▹Project management experience
• ▹Analytical and problem-solving abilities
• ▹Self-driven, action- and detail-oriented, positive attitude in a dynamic environment
• ▹Strong communication and interpersonal skills, ability to plan and drive progress in a complex, interdisciplinary environment
• ▹Fluent in English (both verbal and written)
• ▹Willing to travel up to 30-60 days a year (with flexibility according to client needs)

Nice to have

• ▹Familiarity with equipment commissioning (URS, risk management, FAT/SAT, validation and operating/maintaining of equipment)

Soft skills

About the company

The client develops and optimizes products and production lines in close dialogue with customers and partners, also offering consultants for production support, optimization, validation, project management and quality assurance, often to leading international companies.