Senior Validation Specialist
5 hours ago
Job Description:
We are seeking a skilled Validation Engineer to join our team at MP Solutions Kft. As a Validation Engineer, you will play a crucial role in ensuring that products, systems, and processes meet specified requirements and standards before release to the market or implementation.
About Us:
Our client is a leading international company in the field of MedTech, pharmaceuticals, biotechnology, medical devices, and manufacturing. We offer a range of services, including production support, optimization, validation, project management, and quality assurance.
Your Role:
- Develop and execute validation plans, conducting tests, and documenting results to confirm compliance and functionality.
- Ensure that products, equipment, systems, and processes comply with regulatory requirements, industry standards, and company-specific guidelines.
- Collaborate with Quality Assurance and Regulatory Affairs teams to ensure and maintain compliance.
- Work closely with R&D and manufacturing to integrate validation processes into project development workflows.
Key Responsibilities:
- Developing and executing qualification protocols for installation (IQ), operational performance (OQ), and performance load (PQ).
- Executing risk assessments and gap analyses on systems or processes.
- Ensuring documentation complies with industry regulations (e.g., FDA, ISO, GMP).
- Identifying and reporting any validation deviations and proposing corrective actions in collaboration with QA functions.
Requirements:
- Minimum +6 years of experience in validation, quality assurance, or a related role.
- Bachelor's degree in Engineering (e.g., mechanical engineering, production engineering, or similar).
- Proficiency in validation tools and software.
- Knowledge of regulatory standards (FDA, GMP, ISO, etc.).
- Familiarity with statistical analysis and risk assessment programs.
- Project management skills.
Benefits:
- Home office option.
- Opportunity to work on complex and interdisciplinary projects.
- Fluent English communication skills.
- Travel up to 20-30 days per year.
Additional Requirements:
- Analytical and problem-solving abilities.
- Self-driven, action-oriented, and detail-focused individual.
- Ability to navigate professionally in a dynamic environment.
What We Offer:
- A flat structure with short decision-making paths.
- A pioneering spirit and ambitious atmosphere.
- The opportunity to make an impact in your job function and daily work.
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