Validation Project Engineer GMP (Freelance optional)
Omschrijving
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📋 Tasks and responsibilities
As Project Engineering support, you coordinate validation and planning activities within capital projects. This includes preparing schedules, maintaining project plans, and ensuring that validation work is aligned with project objectives and quality expectations.
You interpret and apply GMP requirements, relevant international standards such as ISO and ICH, and internal quality procedures. You coordinate verification and validation activities, prepare and review validation documentation, and act as a key point of contact for Engineering and Quality Assurance on validation and change control topics.
Your responsibilities also include facilitating Quality Risk Assessments and providing expertise in verification, validation, and quality risk management. In addition, you support one or more products or projects by handling urgent quality investigations, carrying out risk assessments, implementing changes, and contributing to the introduction of new products.
In a laboratory environment, the role also covers qualification and validation related to method improvements, the development of computer-controlled systems, and backup support for other project engineers where needed.
Qualifications
For this role, you preferably hold a master's degree in civil engineering, industrial engineering, bio-engineering, industrial pharmacy, another scientific discipline, or equivalent experience.
Experience in a production environment and within the pharmaceutical sector is considered a strong asset, particularly with aseptic processes, cleaning, disinfection, and sterilization.
You combine strong communication and stakeholder management skills with a structured way of working, accuracy, and solid technical writing abilities. A good command of Dutch and English is required.
You are comfortable working within a structured framework, completing clearly defined tasks, following established procedures, and supporting routine operational activities in a reliable and timely manner.
💼 Offer
You will be part of a growing Belgian SME where initiative and personal development are encouraged. We will provide you with an enjoyable work environment with fun colleagues. We will work out a career plan with you, with attention and a budget for extra education/certification. You can count on an attractive salary, supplemented with extra-legal benefits, including a company car.
(Freelance is also possible)