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Job Overview
We are seeking a highly skilled professional to fill the position of Validation Engineer. The successful candidate will play a critical role in supporting our validation activities for new tools and product introductions.
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Main Responsibilities
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* Develop and execute process validation protocols and reports for new product introductions and revalidations.
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* Implement solutions to sustain and improve our Quality Management System (QMS).
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* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
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* Participate in site change control, ensuring effective implementation of changes to validated processes.
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* Generate risk assessments for cleaning, validation, and process.
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* Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
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* Support GMP and regulatory audits.
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* Analyze data and make informed decisions based on conclusions reached from analysis.
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Requirements
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* A third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
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* Experience in statistical analysis (Minitab) / SPC / validations.
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* Excellent interpersonal, communication, influencing, and facilitation skills.
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* A minimum of two years experience as a Validation Engineer in an injection moulding or medical manufacturing environment.
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* Minimum of five years experience working with Medical Devices.
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Desirable Skills
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* Polymer expertise.
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* Injection moulding knowledge.
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* Lean six methods.
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* Minitab.
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