上海招聘

Process Engineer with API & Biotech Experience

Job Description:

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.

· Commissioning and Qualification of 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.

? Preparation of process building layout together with architects.

? Analysis of supplier quotations for machinery & equipment, comparison & selection.

? 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.

Commissioning and qualification:

? Writing FAT, SAT and give input to IQ and OQ protocols and test plans.

? 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:

- Bioreactor and fermentation design or operation.

- Chemical synthesis

- Recovery.

§ Centrifugation

§ Flocculation

§ Extraction

§ Filtration

- Purification

§ Gas and liquid Filtration

§ Membrane technology – UF, osmosis, electro dialysis etc.

§ Chromatography or ion exchange

§ Crystallisation or precipitation

§ Chemical reactions

§ Distillation

§ Drying processes - Spray drying, freeze drying etc.

- Contamination strategies.

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

- Vaccines.

- Sterile products.

• GMP knowledge is preferable.
• Good computer skill in P&ID, AutoCAD.
• Operation Flow diagrams (OFD), PMD.

Personal qualifications

• Taking responsibility
• Proactive and ensure cooperation with and between other disciplines.
• Positive and flexible attitude
• Good communication skills

Pls. send your CV and expected salary to npshhr@nnepharmaplan.com

恩宜珐玛在医药生物工程领域是世界上最领先的工程咨询公司。我们的业务涵盖生物制药，疫苗及医疗器械，帮助客户开发、建立和改进他们的生产。恩宜珐玛在全球超过25个地方拥有将近1600名员工。

“Engineering for a healthier world” 是我们的使命。我们致力于改善全人类生活的事业。

恩宜珐玛在1995年进入中国，总部位于天津，分公司分布在上海和广州。

在中国，恩宜珐玛拥有400名员工，涵盖所有工程专业，为客户提供全面的工程服务。我们对整个供应链有独到的见解，以广为认可的项目执行模式，15年来为国内客户提供一流工程服务，服务范围包括，咨询，前期调研，工程，项目和施工管理到试运行和验证，以及全套的自动化解决方案，洁净室和模块化设施等。