(高级)工艺开发工程师

岗位职责：
1. Conduct testing and implementation of process changes, andinvestigate manufacturing process issues.
测试和实施工艺变更，调查研究生产工艺的相关问题。
2. Design and execute experiments in the PSPD（Process Science &Process Development) lab, analyze data, participate in root causeanalysis, prepare reports and support follow-ups.
在工艺实验室设计和完成实验，分析数据，参与原因分析，撰写报告并支持后续工作。
3. Conduct process validation work in collaboration with Manufacturing,QC and QA departments.
与生产、QC和QA部门配合完成工艺验证工作。
4. Prepare validation and monitoring plans, collect, compile and analyzedata, prepare reports and support follow-ups.
制定验证和监控计划，收集、整理和分析数据，准备报告并支持后续工作。
5. Support other process development work as needed.
支持其他工艺研发相关工作。

任职要求：
1. Master degrees in bio/chemical engineering or similar backgrounds.
具有硕士学历，生物工程，化学工程或相关背景。
2. Three (3) years + work experience in the pharmaceutical or biotech industries.
具有三年或以上制药或生物技术行业工作经验。
3. Work experience in process development, process validation, techtransfer and/or manufacturing.
具有工艺开发，工艺验证，技术转移或生产方面的工作经验。
4. Knowledge of DOE, SPC and other relevant engineering statistics.
对工程统计学有一定的了解，如了解DOE， SPC等。
5. Knowledge of cGMP would be an asset.
了解cGMP者优先。
6. Knowledge of mammalian cell biology or cell therapy would be an asset.
了解哺乳类细胞生物学或细胞治疗者优先。
7. Good interpersonal skills to work in a multidisciplinary,collaborative environment and to interact with external partiesprofessionally. Self-starter and fast learner.
良好的人际沟通和协作能力，内驱力和快速学习能力。