Process -With Finished Goods Experience（Oral Solid Dosage）

The employee’s responsibilities are:

· Design and optimize scalable processes for biotech or pharmaceutical factory in close cooperation with other disciplines and clients.

· 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.

· Commissioning and Qualification of process equipment according to cGMP.

The employee must undertake some of the basic activities in connection with project ution:

Basic design:

· Establishment of User Requirements Specifications (URS).

· Requirements Classifications.

· Preparation of process building layout together with architects.

· Analysis of supplier quotations for machinery & equipment, comparison & ion.

· Initial HSE (Health, Safety and Environment) evaluation.

· Risk Assessment.

· PFD, Process Flow Description.

· PID, Process & Instrumentation Diagram.

· Production and utility capacity calculations.

Detailed Design:

· Tender materials and ordering of machinery & equipment.

· Establishment of project plan.

· Design Review.

· Writing FAT and SAT documents and give input to IQ and OQ protocols and test plans.

Commissioning and qualification:

· Execution of FAT, SAT, IQ and OQ on process and clean utility equipment.

· Supplier follow-up.

Other activities:

· Coordination between customers, suppliers, QA, technical purchasing.

· Secure planning of test items.

· Financial status & follow-up.

· Overview of the project.

Technical Qualification:

·   Minimum 5 years’ technical experience.

·    You have experience in one or more part below:

o  Pharmaceutical Manufacturing Equipment – solid dosage form, devices, sterile product etc.

o  Clean utility – Purified Water (PW), Water for Injection (WFI), clean steam, process air, clean in place (CIP) etc.

o   Layout/Room Classifications/Flows of personal, raw material etc.

o  Wash & Sterilization, Filing technologies.

o  Warehouse & Logistic.

o  Laboratory

o  Production or process development.

·   GMP knowledge is preferable.

·   Good computer skill in P&ID, AutoCAD.

Personal qualifications

·      Taking responsibility

·      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

 Optimize processes with the business drives; Builds up a strong and efficient team through leadership