CSV Engineer
Description du poste
You can find all of our job offers by clicking here:
https://www.teoxane.com/ (https://www.teoxane.com/)
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Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They specialize in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners can fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has total freedom of thought, action and innovation which makes the company unique.
In the frame of the growth of our business, we are looking for an:
CSV Engineer
Main activities
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Manage and validate embedded computerized systems integrated into industrial equipment.
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Execute validation activities specifically related to embedded systems, in compliance with applicable regulations and internal procedures.
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Support the validation team in the planning, execution, and documentation of system validation tasks.
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Drive continuous improvement initiatives in the Embedded Computerized System Validation process.
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Author and maintain validation documentation, including protocols (IQ/OQ/PQ), test plans, and technical reports, specifically for embedded systems.
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Act as a subject matter expert for embedded system validation during internal and external audits.
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Collaborate with engineering, automation, and quality teams to ensure compliance and performance of embedded systems.
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Ensure adherence to safety protocols and report any potential risks or unsafe conditions.
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Apply and promote the use of appropriate personal and collective protective equipment.
Your Profile
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Engineering degree or equivalent university education in automation, electronics, computer science, or related field.
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Minimum 7 years of experience in embedded system validation within the pharmaceutical or medical device industry.
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Solid knowledge of commissioning and qualification of industrial equipment with embedded control systems.
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Familiarity with regulatory requirements (e.g., GAMP 5, 21 CFR Part 11, EU Annex 11) as they apply to embedded systems.
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Strong technical writing and documentation skills.
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Excellent communication and interpersonal skills; ability to work cross-functionally.
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Proactive, organized, and solution-oriented mindset.
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Fluent in both French and English.
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