Job Title: Advanced Technical Specialist
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The role of an Advanced Technical Specialist involves providing expert technical guidance and leadership within the engineering domain. This includes application of broad knowledge in principles, practices, and procedures to deliver complex assignments.
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Responsibilities:
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* Define precise functional requirements for new equipment;
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* Design, test, and integrate components effectively;
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* Evaluate overall effectiveness, cost, reliability, and safety;
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* Develop specifications and process validation plans;
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* Create and review material part specifications and bills of materials;
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* Implement supporting documentation, SOPs, and process work instructions compliant with GMP standards;
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* Provide technical guidance to engineers and technicians;
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* Conduct process validation for products and processes, including VP, IQ, OQ, PQ, and related documentation;
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* Apply a prioritized approach to improve quality, service, and cost using Value Centred Engineering methods;
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* Assist in developing a world-class manufacturing group proficient in process improvement and problem-solving using Six Sigma tools;
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* Monitor line performance and develop structured plans to address systemic issues affecting performance.
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Required Skills and Qualifications:
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* Bachelor's degree or higher in Engineering;
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* Minimum 4 years of experience in medical devices manufacturing environment;
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* Strong communication, influencing, project management, and technical leadership skills;
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* Proven decision-making confidence and leadership capabilities in negotiations.
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