职责描述：
Job Description:

With special focus on Clean Utility, the employee’s responsibilities are:
• Design and optimize scalable processes for biotech or pharmaceutical factory in close cooperation with other disciplines
• Select process equipment and determine critical process parameters relevant for design of production process or scale-up
• Design, optimize, and specify new process equipment; compile user requirement documents
• Qualify process equipment according to cGMP
The employee must undertake the basic activities in connection with project execution:
Basic design:
• Establishment of User Requirements Specifications (URS)
• Requirements Classifications
• Quality Activity Plan (QAP)
• Analysis of supplier quotations for machinery & equipment, comparison & selection
• Initial HSE evaluation
• Risk Assessment
• PFD, Process Flow Description
• PID, Piping & Instrumentation Diagram
Detailed Design:
• Tender materials and ordering of machinery & equipment
• Establishment of project plan
• Supplier follow-up
• Design Review
• Writing FAT, SAT and give input to IQ and OQ protocols and test plans
• Execution of FAT, SAT, IQ and OQ
Other activities:
• Coordination between customers, suppliers, QA, technical purchasing
• Secure planning of test items
• Financial status & follow-up
• Overview of the project

任职要求：
Qualification:
• Bachelor or Master Degree.
• Minimum 10 years of relevant experience:
-Pharmaceutical Water, Steam and Compressed air
-Cleaning, cleaning systems (CIP/SIP technologies) and cleaning validation
-Regulatory requirements and guidelines on these areas.
• Proactive and ensure cooperation with and between other disciplines.
• Positive and flexible attitude.
• Good communication skills.


Other Requirements:
• Accountable for results with proactive attitude
• Creative, self-motivated, actively participate in specific initiatives and promote positive company culture
• Open-minded and ready for change
• Cooperate and collaborate with business partners with good teamwork spirit
• Customer focus, understand and satisfy internal and external customers
• Continuously improve,
• Excellent communication, negotiation and interpersonal skills in English and Chinese
• Detail-oriented with good planning and organizing skill
• Provide high quality solution for customer and work in an efficient and timely manner