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高级技术工程师

1.5-2万
苏州市本科不限经验

职位描述

Key Responsibilities岗位描述:
Product Customization:
-Gain an understanding of the packaging requirements of each customer and the general usage scenarios including drug/package interactions for each product produced .
-Advise on the selection of appropriate aluminum canisters based on propellants, APIs, and coatings for specific pharmaceutical applications.
- Develop Specifications for Anomatic Pharma products
Validation Support:
-Assist in designing and executing validation protocols for canister applications, ensuring products consistently meet regulatory and quality requirements.
Technical responsibilities :
-Serve as the primary technical contact for customers, addressing technical queries and ensuring effective communication between internal teams and external sides including customers , suppliers …
-Identify key requirements and oversee technical interactions with suppliers
-Direct responsibility for Homologating (gaining regulatory approval) of new products
- Conduct structured problem-solving measures for non-compliant products .
Data Analysis and Reporting:
-Analyze validation data, generate technical reports, and contribute to the development of scientific marketing materials such as datasheets, whitepapers, and technical posters.
Process Improvement:
-Collaborate with operations and quality teams to refine existing processes and develop robust standard operating procedures (SOPs) tailored to application-specific requirements.
- Participate in FDA , ISO and other needed QA/manufacturing certifications to support product line
Regulatory Support:
-Support regulatory submissions by providing detailed technical documentation and validation reports as needed.
-Participate in technical conferences in the applied fields, Maintain technical competence .
Capabilities & Skill 技能要求:
Technical Proficiency:
In-depth understanding of materials, coatings, and pharmaceutical packaging requirements.
Analytical Skills:
-Strong ability to analyze data, interpret validation results, and document technical processes.
Communication:
-Excellent written and verbal communication skills, with the ability to translate complex technical data into clear, actionable insights for diverse audiences.
Problem-Solving:
-A proactive approach to identifying potential issues and implementing effective solutions.
Team Player:
-Collaborative and adaptable, with a proven track record of working effectively across multifunctional teams.
Customer Focus:
-A strong commitment to understanding customer requirements and building trust through productive technical relationships.
Qualifications and Experience
-Academic Requirements:
-Bachelor’s degree in Engineering, Materials Science, Chemistry, or a related discipline; a Master’s degree is preferred.
Professional Experience:
-Minimum of 2-3 years’ experience in a technical role within medical or the pharmaceutical packaging design and a related manufacturing industry.
-Prior experience in technical validation and regulatory documentation is highly desirable.
-Must be a fluent English speaker 。
-Master’s Degree or higher in Chemistry, Chemical Engineering, Material Science or other Medical Packaging related science.
-Ability to work independently ,while also serving as an active team player
-Proficiency in : MS office , CAD drafting (3D), Statistical Analysis software
Preferred Experience:
-Experience in the inhalation industry.
-A 'driver attitude'—demonstrating strong initiative and the ability to lead improvements.
Collaboration
-Requires close collaboration with multiple departments including Operations, Quality Assurance, and Sales.
A strong customer-facing and advisory approach is essential to support client engagement and foster long-term relationships.

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