Our client are developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. The company also offers consultants for production support, optimization, validation; project management and quality assurance just to name a few. The customers are often the leading international companies in their specific field
Position:
As Validation Engineer you play a crucial role in ensuring that products, systems, and processes meet specified requirements and standards before released to the market or implemented. The Validation Engineer ensures that products, equipment, systems, and processes comply with regulatory requirements, industry standards, and company-specific guidelines. This role involves developing and executing validation plans, conducting tests, and documenting results to confirm compliance and functionality.
Key Responsibilities:
o URS, DQ, FAT, SAT, IQ, OQ, PQ
o Develop validation protocols for systems, equipment and/or processes
o Execute qualification protocols for installation (IQ), operational performance (OQ) and performance load (PQ)
o Execute risk assessments and gap analyses on systems or processes, pFMECA, Hazard
o Ensure documentation complies with industry regulations (e.g., FDA, ISO, GMP)
o Identify and report any validation deviations and propose corrective actions in collaboration with QA functions
You ensure all validation activities align with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 9001, ISO 13485). You collaborate with Quality Assurance an Regulatory Affairs teams to ensure and maintain compliance. You work closely with R&D and manufacturing to integrate validation processes into project development workflows as well as you ongoing analyze validation processes to identify opportunities for improvement.
Requirements
- You have minimum +6 years of experience in in validation, quality assurance, or a related role in industries such as MedTech, pharmaceuticals, biotechnology, medical devices or manufacturing.
- You have a min Bachelor´s degree in Engineering (e.g. mechanical engineering, productions engineering or similar).
- You have gained experience with designing and executing tests, with writing and reviewing scientific with a high technical complexity, and you are familiar with both production (including GMP and QA).
- Proficiency in validation tools and software
- Knowledge of regulatory standards (FDA, GMP, ISO, etc.)
- Familiarity with statistical analysis and risk assessment programs
- Maybe you are familiar with equipment commissioning (URS, risk management, FAT/SAT, validation and operating/maintaining of equipment and moulds)
- Project management
- You have analytical and problem-solving abilities.
- You are self-driven, action- and detail-oriented and you can navigate professionally in and dynamic environment. You have a positive attitude.
- Due to your strong communication and interpersonal skills and your approach to planning, you ensure progress in a complex and interdisciplinary environment.
- You are fluent in English (both in verbal and in writing).
- you are willing to travel up to 30-60 days a year (with flexibility according to client needs) and you will have the chance to meet new cultures, new companies, crossfunctional teams – to increase your competences
Benefits
You get great opportunity to make an impression on your job function and your daily work. The policy of the company is always to meet customers′ requirements and expectations. It is a company with flat structure, short decision-making paths. There is an ambitious atmosphere and pioneering spirit in the workplace. Focus on developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. The team (today about 40 people) consists of dedicated engineers, technicians and sales representatives, all of whom are highly qualified within their specific professions.