Job Description:
With special focus on Clean Utility, the employee’s responsibilities are:
1. Design and optimize scalable processes for biotech or pharmaceutical factory in close cooperation with other disciplines
2. Select process equipment and determine critical process parameters relevant for design of production process or scale-up
3. Design, optimize, and specify new process equipment; compile user requirement documents
4. Qualify process equipment according to cGMP
The employee must undertake the basic activities in connection with project ution:
Basic design:
· Establishment of User Requirements Specifications (URS)
· Requirements Classifications
· Quality Activity Plan (QAP)
· Analysis of supplier quotations for machinery & equipment, comparison & ion
· 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
Qualification:
· Bachelor or Master Degree.
· Minimum 5 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,
· Good 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
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